FDA Product Code
FDA Product Code FMI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5570
510(k) Clearances — 694 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261266 | MOWANA Auto Duo | PENTAMASTER MEDIQ SDN BHD | 2026-09-17 | Traditional | PDF ↗ |
| K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2026-08-25 | Special | PDF ↗ |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | 2026-08-10 | Special | PDF ↗ |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 | Traditional | PDF ↗ |
| K261829 | Profoject Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 | Traditional | PDF ↗ |
| K260739 | Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 | Traditional | PDF ↗ |
| K260855 | Profoject Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 | Traditional | PDF ↗ |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 | Special | PDF ↗ |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | 2026-03-25 | Special | PDF ↗ |
| K253047 | PRESSONE | Nipro Medical Corporation | 2026-03-24 | Traditional | PDF ↗ |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 | Traditional | PDF ↗ |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 | Traditional | PDF ↗ |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 | Traditional | PDF ↗ |
| K252631 | Profoject Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 | Traditional | PDF ↗ |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 | Traditional | PDF ↗ |
| K250284 | TSK SELECT Needle | Tsk Laboratory, Japan | 2025-07-24 | Traditional | PDF ↗ |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025-07-08 | Traditional | PDF ↗ |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 | Special | PDF ↗ |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 | Traditional | PDF ↗ |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 | Traditional | PDF ↗ |
| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 | Special | PDF ↗ |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 | Special | PDF ↗ |
| K242741 | ACE Cannula | Ace Medical Industry Co., Ltd. | 2025-01-08 | Traditional | PDF ↗ |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 | Special | PDF ↗ |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | 2024-07-02 | Traditional | PDF ↗ |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Berpu Medical Technology Co., Ltd. | 2024-02-01 | Traditional | PDF ↗ |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | 2023-12-12 | Traditional | PDF ↗ |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | 2023-11-27 | Abbreviated | PDF ↗ |
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® | Promamedical, Inc. | 2023-10-05 | Abbreviated | PDF ↗ |
| K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 | Traditional | PDF ↗ |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023-09-14 | Traditional | PDF ↗ |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K231255 | NovoFine® Plus | Novo Nordisk, Inc. | 2023-08-25 | Special | PDF ↗ |
| K231261 | Altaviz Needle Kit II | Altaviz, LLC | 2023-07-27 | Traditional | PDF ↗ |
| K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2023-07-25 | Special | PDF ↗ |
| K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2023-06-02 | Traditional | PDF ↗ |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | 2023-05-25 | Traditional | PDF ↗ |
| K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | 2023-04-06 | Traditional | PDF ↗ |
| K222417 | Shina Safety Needle | Shina Corporation | 2023-03-20 | Traditional | PDF ↗ |
| K223327 | Sterile Aesthetic Cannula and Hypodermic Needle | Shanghai Kindly Enterprise Development Group Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-15 | Traditional | PDF ↗ |
| K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle | Pikdare Spa | 2023-01-20 | Abbreviated | PDF ↗ |
| K223286 | BD AutoShield Duo Pen Needle | Becton, Dickinson and Company | 2022-12-28 | Traditional | PDF ↗ |
| K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | 2022-12-13 | Traditional | PDF ↗ |
| K222681 | Altaviz Needle Kit | Altaviz, LLC | 2022-12-05 | Traditional | PDF ↗ |
| K223353 | DropSafeTM SicuraTM | Pikdare Spa | 2022-12-02 | Traditional | PDF ↗ |
| K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2022-11-17 | Traditional | PDF ↗ |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-11-04 | Traditional | PDF ↗ |
| K220890 | IO Needle Safety Sheath | Actuated Medical, Inc. | 2022-10-31 | Traditional | PDF ↗ |
| K213183 | Safety Insulin Pen Needles | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-10-14 | Traditional | PDF ↗ |
| K221066 | Sterile Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K221080 | Sterile Safety Hypodermic Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-09-19 | Traditional | PDF ↗ |
| K220603 | Disposable Medical Safety Hypodermic Needle | Hantech Medical Device Co., Ltd. | 2022-08-23 | Traditional | PDF ↗ |
| K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | 2022-08-22 | Traditional | PDF ↗ |
| K221176 | Insulin Pen Needle | Tianjin Huahong Technology Co., Ltd. | 2022-07-01 | Special | PDF ↗ |
| K213478 | BD Pen Needle | Becton, Dickinson and Company | 2022-06-28 | Traditional | PDF ↗ |
| K220614 | MEDOJECT fine Pen Needles | Chirana T. Injecta | 2022-06-15 | Traditional | PDF ↗ |
| K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-05-13 | Traditional | PDF ↗ |
| K212514 | Safety Pen Needle for Single Use, Insulin Pen Needles | Berpu Medical Technology Co., Ltd. | 2022-04-29 | Traditional | PDF ↗ |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-04-12 | Traditional | PDF ↗ |
| K210864 | Safety Pen Needle | Sandstone Medical (Suzhou), Inc. | 2022-02-17 | Traditional | PDF ↗ |
| K211716 | DropSafe Safety Pen Needles | Htl Strefa SA | 2022-01-07 | Traditional | PDF ↗ |
| K213407 | UltiCare Disposable Pen Needles | Ultimed Incorporated | 2021-12-16 | Traditional | PDF ↗ |
| K200932 | Blood Collection Needles | Vacutest Kima Srl | 2021-12-14 | Traditional | PDF ↗ |
| K213156 | BD Nano 2nd Gen Pen Needle | Becton, Dickinson and Company | 2021-12-08 | Special | PDF ↗ |
| K212015 | BD Nano 2nd Gen Pen Needle | Becton, Dickinson and Company | 2021-11-19 | Traditional | PDF ↗ |
| K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | Tianjin Huahong Technology Co., Ltd. | 2021-11-12 | Traditional | PDF ↗ |
| K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | 2021-10-14 | Traditional | PDF ↗ |
| K212805 | SteriCap Mini Needle and Standard Needles | Ocuject, LLC | 2021-09-30 | Special | PDF ↗ |
| K210232 | Sterile Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K210399 | Unifine SafeControl | Owen Mumford, Ltd. | 2021-09-17 | Special | PDF ↗ |
| K211634 | Hypodermic Needle-Pro EDGE Safety Device | Smiths Medical Asd, Inc. | 2021-08-26 | Special | PDF ↗ |
| K211395 | NIO-I | Einstein Works, LLC | 2021-07-28 | Traditional | PDF ↗ |
| K211968 | NIO+ Adult | Waismed, Ltd. | 2021-07-22 | Special | PDF ↗ |
| K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021-07-21 | Traditional | PDF ↗ |
| K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2021-06-25 | Traditional | PDF ↗ |
| K210258 | NovoFine | Novo Nordisk, Inc. | 2021-06-23 | Traditional | PDF ↗ |
| K210065 | Verifine Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021-04-22 | Traditional | PDF ↗ |
| K202492 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2021-03-22 | Traditional | PDF ↗ |
| K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | Sandstone Medical (Suzhou), Inc. | 2021-02-02 | Traditional | PDF ↗ |
| K202681 | Promisemed Covered Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 | Special | PDF ↗ |
| K202005 | NovoFine Plus 32G Tip x 4 mm | Novo Nordisk, Inc. | 2020-12-19 | Traditional | PDF ↗ |
| K202682 | Promisemed Triple Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020-11-24 | Special | PDF ↗ |
| K200017 | Eclipse DermaFlex Cannula | Eclipse Medcorp, LLC | 2020-11-05 | Traditional | PDF ↗ |
| K202340 | Droplet Pen Needle 30G & 33G | Htl-Strefa S.A | 2020-10-15 | Traditional | PDF ↗ |
| K192464 | Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. | 2020-08-25 | Traditional | PDF ↗ |
| K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-06 | Traditional | PDF ↗ |
| K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020-05-12 | Traditional | PDF ↗ |
| K192082 | Droplet Pen Needle 34G | Htl-Strefa S.A | 2020-04-21 | Traditional | PDF ↗ |
| K190962 | Bella-mu | U-Needle B.V. | 2020-02-03 | Traditional | PDF ↗ |
| K191643 | TK Sterile Hypodermic Needle | Anhui Tiankang Medical Technology Co., Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K191488 | SAM IO Intraosseous Access System | Sam® Medical Products, Inc. | 2019-11-21 | Traditional | PDF ↗ |
| K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | 2019-11-13 | Traditional | PDF ↗ |
| K191258 | Intraosseous infusion device | Einstein Works, LLC | 2019-10-23 | Traditional | PDF ↗ |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | Terumo Europe N.V. | 2019-10-11 | Special | PDF ↗ |
Product code FMI · Class II · General Hospital. Data: openFDA.