FDA Product Code
FDA Product Code MED — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6885
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2026-04-08 | Traditional | PDF ↗ |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | STERIS Corporation | 2023-10-03 | Special | PDF ↗ |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2023-03-28 | Special | PDF ↗ |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2022-09-28 | Special | PDF ↗ |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2021-09-07 | Traditional | PDF ↗ |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | STERIS Corporation | 2021-05-12 | Special | PDF ↗ |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | 2019-12-10 | Special | PDF ↗ |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation | 2019-09-05 | Special | PDF ↗ |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System | Steris Corporations | 2019-03-22 | Special | PDF ↗ |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | 2019-01-31 | Traditional | PDF ↗ |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing System | Steris Corporations | 2018-04-04 | Special | PDF ↗ |
| K173256 | System 1 endo Liquid Chemical Sterilant Processing System | STERIS Corporation | 2018-03-02 | Traditional | PDF ↗ |
| K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2017-09-22 | Traditional | PDF ↗ |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2016-08-05 | Special | PDF ↗ |
| K140703 | OPA 30 SOLUTION | Ciden Technologies, LLC | 2014-08-19 | Traditional | PDF ↗ |
| K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | 2013-07-05 | Special | PDF ↗ |
| K120306 | RAPICIDE OPA-28 | Minntech Corp. | 2012-09-27 | Traditional | PDF ↗ |
| K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | 2012-02-21 | Special | PDF ↗ |
| K113015 | ALDAHOL V HIGH LEVEL DISINFECTANT | Microchem Laboratories, Inc. | 2012-01-30 | Traditional | PDF ↗ |
| K102462 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | STERIS Corporation | 2010-09-21 | Special | PDF ↗ |
| K101409 | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM | STERIS Corporation | 2010-08-02 | Special | PDF ↗ |
| K091022 | MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT | STERIS Corporation | 2010-04-12 | Traditional | PDF ↗ |
| K090036 | SYSTEM 1.5 STERILE PROCESSING SYSTEM | STERIS Corporation | 2010-04-05 | Traditional | PDF ↗ |
| K091890 | EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT | Healthpoint, Ltd. | 2010-03-24 | Traditional | PDF ↗ |
| K091210 | ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT | Best Sanitizers, Inc. | 2010-02-05 | Traditional | PDF ↗ |
| K080420 | RESERT XL HLD HIGH LEVEL DISINFECTANT | STERIS Corporation | 2008-09-02 | Traditional | PDF ↗ |
| K070627 | OPACIDEN SOLUTION | Ciden Technologies, LLC | 2007-08-02 | Traditional | PDF ↗ |
| K063159 | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | Puricore, Inc. | 2007-04-02 | Traditional | PDF ↗ |
| K061356 | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 | Advanced Infusion, Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K060618 | CIDEX ACTIVATED DIALDEHYDE SOLUTION | Johnson & Johnson Co. | 2006-04-12 | Special | PDF ↗ |
| K041984 | ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT | Best Sanitizers, Inc. | 2005-05-11 | Traditional | PDF ↗ |
| K041360 | ALDAHOL III HIGH-LEVEL DISINFECTANT | Healthpoint, Ltd. | 2005-05-05 | Traditional | PDF ↗ |
| K032959 | CIDEX OPA CONCENTRATE | Advanced Sterilization Products | 2005-04-04 | Traditional | PDF ↗ |
| K033381 | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL | Discus Dental, Inc. | 2004-01-27 | Traditional | PDF ↗ |
| K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT | Pascal Co., Inc. | 2003-05-27 | Traditional | PDF ↗ |
| K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION | Advanced Sterilization Products | 2003-02-27 | Traditional | PDF ↗ |
| K013280 | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | Sterilox Technologies, Inc. | 2002-09-18 | Traditional | PDF ↗ |
| K003087 | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | Sporicidin Intl. | 2000-11-07 | Traditional | PDF ↗ |
| K002401 | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) | Advanced Sterilization Products | 2000-08-29 | Special | PDF ↗ |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | Medivators, Inc. | 2000-08-17 | Traditional | PDF ↗ |
| K001381 | CIDEX OPA SOLUTION | Advanced Sterilization Products | 2000-05-17 | Special | PDF ↗ |
| K991487 | CIDEX OPA SOLUTION | Advanced Sterilization Products | 1999-10-08 | Traditional | PDF ↗ |
| K972708 | ENDO-SPOR PLUS / HYPROCIDE | Cottrell, Ltd. | 1999-09-13 | Traditional | PDF ↗ |
| K984270 | VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 | Roger L. Goodman, D.D.S., P.C. | 1999-05-20 | Traditional | PDF ↗ |
| K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION | Reckitt Benckiser, Inc. | 1999-03-30 | Special | PDF ↗ |
| K983194 | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) | Sporicidin Intl. | 1999-03-05 | Traditional | PDF ↗ |
| K974188 | CETYLCIDE-G | Kellerandheckman | 1998-09-10 | Traditional | PDF ↗ |
| K974062 | MEDSCI 3% GLUTARALDEHYDE | Medsci, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K962959 | PERACIDIN DIALYZER REPROCESSING CONCENTRATE | Hdc Medical, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K970726 | VAPOCIDE | Cottrell, Ltd. | 1998-05-18 | Traditional | PDF ↗ |
| K961289 | VAPOPHENE | Germiphene Corp. | 1997-12-04 | Traditional | PDF ↗ |
| K970230 | SPOROX | Reckitt Benckiser, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K960513 | PERACT 20 LIQUID STERILANT | Minntech Corp. | 1997-10-01 | Traditional | PDF ↗ |
| K914749 | WAVICIDE(R) -01 | Wave Energy Systems, Inc. | 1995-08-10 | Traditional | PDF ↗ |
| K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR | Cottrell, Ltd. | 1995-07-03 | Traditional | PDF ↗ |
| K930284 | METRICIDE | Metrex Research Corp. | 1994-12-06 | Traditional | PDF ↗ |
| K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE | Metrex Research Corp. | 1994-12-06 | Traditional | PDF ↗ |
| K931052 | METRICIDE 28 | Metrex Research Corp. | 1994-12-06 | Traditional | PDF ↗ |
| K932047 | WAVICIDE MONITOR STRIPS | Serim Research Corp. | 1994-06-02 | Traditional | PDF ↗ |
| K924334 | CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE | Johnson & Johnson Medical, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K932740 | HOMEPUMP NSF | Block Medical, Inc. | 1993-10-06 | Traditional | PDF ↗ |
| K915170 | PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR | Pymah Corp. | 1992-07-28 | Traditional | PDF ↗ |
| K913943 | SERIM DISINTEK REAGENT STRIPS | Serim Research Corp. | 1992-03-26 | Traditional | PDF ↗ |
| K875280 | STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT | Steris C/O Medical Device Consultants, Inc. | 1988-09-13 | Traditional | PDF ↗ |
Product code MED · Class II · General Hospital. Data: openFDA.