FDA Product Code
FDA Product Code MQL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6180
510(k) Clearances — 260 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | 2026-08-28 | Traditional | PDF ↗ |
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 | Traditional | PDF ↗ |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 | Traditional | PDF ↗ |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 | Traditional | PDF ↗ |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025-08-26 | Traditional | PDF ↗ |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | 2025-05-30 | Traditional | PDF ↗ |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 | Traditional | PDF ↗ |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 | Traditional | PDF ↗ |
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 | Traditional | PDF ↗ |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | 2025-03-21 | Traditional | PDF ↗ |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 | Traditional | PDF ↗ |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024-12-18 | Traditional | PDF ↗ |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | 2024-12-18 | Traditional | PDF ↗ |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 | Traditional | PDF ↗ |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 | Traditional | PDF ↗ |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | 2024-08-27 | Traditional | PDF ↗ |
| K240605 | Ultra RapidWarm Blast | Vitrolife Sweden AB | 2024-08-07 | Traditional | PDF ↗ |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. | 2024-07-01 | Traditional | PDF ↗ |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-13 | Traditional | PDF ↗ |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | 2024-04-24 | Traditional | PDF ↗ |
| K232125 | V-PVP | Vitromed GmbH | 2024-03-20 | Traditional | PDF ↗ |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-01-30 | Traditional | PDF ↗ |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2023-08-04 | Traditional | PDF ↗ |
| K222606 | V-HYADASE | Vitromed GmbH | 2023-05-26 | Traditional | PDF ↗ |
| K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | 2023-05-11 | Traditional | PDF ↗ |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023-02-10 | Traditional | PDF ↗ |
| K223117 | V-SPERM WASH | Vitromed GmbH | 2023-01-31 | Traditional | PDF ↗ |
| K213293 | V-HEPES PLUS | Vitromed Langenfeld | 2022-09-14 | Traditional | PDF ↗ |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2022-06-16 | Traditional | PDF ↗ |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2022-02-01 | Traditional | PDF ↗ |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUS | Vitrolife Sweden AB | 2021-05-14 | Traditional | PDF ↗ |
| K193285 | V-ONESTEP | Vitromed GmbH | 2020-11-20 | Traditional | PDF ↗ |
| K192503 | GM501 Wash with Phenol Red and Gentamicin | Hamilton Thorne Incorporated | 2020-11-19 | Special | PDF ↗ |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) | Kitazato Corporation | 2020-10-23 | Traditional | PDF ↗ |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2020-10-16 | Traditional | PDF ↗ |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Kitazato Corporation | 2020-08-25 | Traditional | PDF ↗ |
| K192845 | Sperm Freeze, Sperm Fridge | Kitazato Corporation | 2020-08-17 | Traditional | PDF ↗ |
| K200680 | Synvitro Hyadase | Origio A/S, A Coopersurgical Company | 2020-07-17 | Special | PDF ↗ |
| K192644 | GM501 SpermAir and GM501 SpermActive | Hamilton Thorne Incorporated | 2020-04-23 | Traditional | PDF ↗ |
| K190199 | SepaSperm Washing Solution, SepaSperm Solution | Kitazato Corporation | 2019-09-26 | Traditional | PDF ↗ |
| K191552 | GM501 Mineral Oil | Hamilton Thorne, Inc. | 2019-09-18 | Abbreviated | PDF ↗ |
| K190383 | GM501 Wash | Hamilton Thorne, Inc. | 2019-09-05 | Traditional | PDF ↗ |
| K191063 | 1-Step Culture Medium | Shenzhen Vitavitro Biotech Co., Ltd. | 2019-08-23 | Traditional | PDF ↗ |
| K183486 | RapidVit Oocyte, RapidWarm Oocyte | Vitrolife Sweden AB | 2019-07-26 | Traditional | PDF ↗ |
| K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | Fujifilm Irvine Scientific, Inc. | 2019-06-21 | Traditional | PDF ↗ |
| K182002 | Cumulus Remover | Kitazato Corporation | 2018-10-23 | Traditional | PDF ↗ |
| K180073 | Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set | Shenzhen Vitavitro Bio-Tech Co., Ltd. | 2018-08-29 | Traditional | PDF ↗ |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | Origio A/S | 2018-03-02 | Traditional | PDF ↗ |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) | CooperSurgical, Inc. | 2018-03-02 | Traditional | PDF ↗ |
| K171748 | Vitrification Kit and Thawing Kit | Kitazato Corporation | 2017-12-14 | Traditional | PDF ↗ |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | Origio A/S | 2017-10-13 | Traditional | PDF ↗ |
| K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | Genea Biomedx Pty, Ltd. | 2017-09-28 | Traditional | PDF ↗ |
| K171224 | Arctic Sperm Cryopreservation Medium | Irvine Scientific Sales Co., Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K170681 | Continuous Single Culture -NX (CSCM-NX) | Irvine Scientific Sales Co., Inc. | 2017-06-08 | Traditional | PDF ↗ |
| K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | Irvine Scientific Sales Co., Inc. | 2017-06-07 | Traditional | PDF ↗ |
| K162409 | Gems Vitrification Set, Gems Warming Set | Genea Biomedx Pty, Ltd. | 2017-05-24 | Traditional | PDF ↗ |
| K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | Genea Biomedx Pty, Ltd. | 2017-05-12 | Traditional | PDF ↗ |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | CooperSurgical, Inc. | 2017-04-04 | Special | PDF ↗ |
| K170257 | Sydney IVF Culture Oil | William A. Cook Australia Pty. , Ltd. | 2017-02-24 | Special | PDF ↗ |
| K160864 | Cryotop Vitrification Kit and Cryotop Thawing Kit | Kitazato Biopharma Co., Ltd. | 2016-10-07 | Traditional | PDF ↗ |
| K153478 | Sydney IVF Gamete Buffer | William A. Cook Australia Pty. , Ltd. | 2016-08-15 | Traditional | PDF ↗ |
| K160863 | PBS(-), Phosphate Buffered Saline | Kitazato Biopharma Co., Ltd. | 2016-07-28 | Traditional | PDF ↗ |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | Origio A/S | 2016-07-22 | Traditional | PDF ↗ |
| K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit | William A. Cook Australia Pty. , Ltd. | 2016-05-06 | Special | PDF ↗ |
| K152682 | Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit | Willian A. Cook Australia Pty, Ltd. | 2016-05-05 | Special | PDF ↗ |
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit | Irvine Scientific | 2016-05-04 | Traditional | PDF ↗ |
| K160814 | Sydney IVF Sperm Cryopreservation Buffer | William A. Cook Australia Pty. , Ltd. | 2016-04-22 | Special | PDF ↗ |
| K160142 | MINERAL OIL | Kitazato Biopharma Co., Ltd. | 2016-04-21 | Traditional | PDF ↗ |
| K152932 | BlastGen | Origio A/S | 2016-02-29 | Traditional | PDF ↗ |
| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium | William A. Cook Australia Pty. , Ltd. | 2016-01-27 | Special | PDF ↗ |
| K151367 | Sydney IVF Hyaluronidase | William A. Cook Australia Pty. , Ltd. | 2016-01-27 | Traditional | PDF ↗ |
| K150950 | FreezeKit Cleave , ThawKit Cleave | Vitrolife Sweden AB | 2015-12-21 | Traditional | PDF ↗ |
| K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT | William A. Cook Australia Pty. , Ltd. | 2015-12-21 | Special | PDF ↗ |
| K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | William A. Cook Australia Pty. , Ltd. | 2015-12-03 | Special | PDF ↗ |
| K152440 | Sydney IVF PVP | Willam A. Cook Australia Pty, Ltd. | 2015-09-23 | Special | PDF ↗ |
| K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit | William A. Cook Australia Pty. , Ltd. | 2015-08-27 | Special | PDF ↗ |
| K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | Life Global Group, LLC | 2015-02-17 | Traditional | PDF ↗ |
| K143498 | LifeGlobal Global HP | Life Global Group, LLC | 2015-01-20 | Traditional | PDF ↗ |
| K133568 | G-TL | Vitrolife, Inc. | 2014-07-16 | Traditional | PDF ↗ |
| K140317 | EMBRYOGEN | Origio A/S | 2014-06-16 | Traditional | PDF ↗ |
| K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | Origio A/S | 2014-05-14 | Traditional | PDF ↗ |
| K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | Origio A/S | 2014-04-29 | Traditional | PDF ↗ |
| K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | Origio A/S | 2014-04-16 | Traditional | PDF ↗ |
| K113786 | SPERMFREEZE SOLUTION | Vitrolife Sweden AB | 2012-10-26 | Traditional | PDF ↗ |
| K120136 | EMBRYOGEN | Origio A/S | 2012-09-26 | Traditional | PDF ↗ |
| K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | Irvine Scientific Sales Co., Inc. | 2012-07-19 | Traditional | PDF ↗ |
| K121128 | MULTIPURPOSE HANDLING MEDIUM | Irvine Scientific Sales Co., Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | <Genx> Intl., Inc. | 2012-05-03 | Traditional | PDF ↗ |
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | Genx Intl., Inc. | 2011-01-14 | Traditional | PDF ↗ |
| K101003 | RAPIDVIT BLAST, RAPIDWARM BLAST | Vitrolife Sweden AB | 2010-12-10 | Traditional | PDF ↗ |
| K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 | Origio A/S | 2010-08-27 | Traditional | PDF ↗ |
| K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | Nidacon International AB | 2010-06-15 | Traditional | PDF ↗ |
| K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | Genx Intl., Inc. | 2010-06-03 | Traditional | PDF ↗ |
| K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | Genx Intl., Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K093273 | VIT KIT - FREEZE AND THAW | Irvine Scientific Sales Co., Inc. | 2010-03-03 | Traditional | PDF ↗ |
| K082363 | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS | William A. Cook Australia Pty. , Ltd. | 2009-04-29 | Traditional | PDF ↗ |
| K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | Genx Intl., Inc. | 2009-04-24 | Traditional | PDF ↗ |
| K080172 | BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 | Medicult A/S | 2008-12-18 | Traditional | PDF ↗ |
Product code MQL · Class II · Obstetrics/Gynecology. Data: openFDA.