Sterilant, Medical Devices
FDA product code MED · Class II (moderate risk) · 21 CFR 880.6885 · General Hospital
64510(k) clearances
0PMA approvals
18recalls
Manufacturers
- STERIS Corporation 19
- Advanced Sterilization Products 5
- Metrex Research Corp. 3
- Cottrell, Ltd. 3
- Serim Research Corp. 2
- Healthpoint, Ltd. 2
- Best Sanitizers, Inc. 2
- Ciden Technologies, LLC 2
- Sporicidin Intl. 2
- Steris Corporations 2
- Reckitt Benckiser, LLC 2
- Minntech Corp. 2
- Germiphene Corp. 1
- Hdc Medical, Inc. 1
- Medsci, Inc. 1
- Wave Energy Systems, Inc. 1
- Johnson & Johnson Medical, Inc. 1
- Medivators, Inc. 1
- Sterilox Technologies, Inc. 1
- Pymah Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
| K232914 | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid…MED · Special | STERIS Corporation | 10/03/2023SE |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900MED · Special | STERIS Corporation | 03/28/2023SE |
| K222615 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 09/28/2022SE |
| K211607 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Traditional | STERIS Corporation | 09/07/2021SE |
| K210737 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 05/12/2021SE |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical…MED · Special | STERIS Corporation | 12/10/2019SE |
| K191343 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900MED · Special | STERIS Corporation | 09/05/2019SE |
| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
| K180342 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED · Special | Steris Corporations | 04/04/2018SE |
| K173256 | System 1 endo Liquid Chemical Sterilant Processing SystemMED · Traditional | STERIS Corporation | 03/02/2018SE |
| K170956 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED · Traditional | STERIS Corporation | 09/22/2017SE |
| K161683 | SYSTEM 1E Liquid Chemical Sterilant Processing SystemMED · Special | STERIS Corporation | 08/05/2016SE |
| K140703 | Opa 30 SolutionMED · Traditional | Ciden Technologies, LLC | 08/19/2014SE |
| K131078 | System 1E Liquid Chemical Sterilant Processing SystemMED · Special | STERIS Corporation | 07/05/2013SE |
| K120306 | Rapicide OPA-28MED · Traditional | Minntech Corp. | 09/27/2012SE |
| K113520 | System 1E Liquid Chemical Sterilant Processing SystemMED · Special | STERIS Corporation | 02/21/2012SE |
| K113015 | Aldahol V High Level DisinfectantMED · Traditional | Microchem Laboratories, Inc. | 01/30/2012SE |
| K102462 | System 1E Liquid Chemical Sterilant Processing SystemMED · Special | STERIS Corporation | 09/21/2010SE |
| K101409 | System Ie Liquid Chemical Cterilant Processing SystemMED · Special | STERIS Corporation | 08/02/2010SE |
| K091022 | Modification to Resert XL HLD High Level DisinfectantMED · Traditional | STERIS Corporation | 04/12/2010SE |
| K090036 | System 1.5 Sterile Processing SystemMED · Traditional | STERIS Corporation | 04/05/2010SE |
| K091890 | Extended Use Aldahol High Level DisinfectantMED · Traditional | Healthpoint, Ltd. | 03/24/2010SE |
| K091210 | Acecide-C High Level Disinfectant and SterilantMED · Traditional | Best Sanitizers, Inc. | 02/05/2010SE |
| K080420 | Resert XL HLD High Level DisinfectantMED · Traditional | STERIS Corporation | 09/02/2008SE |
| K070627 | Opaciden SolutionMED · Traditional | Ciden Technologies, LLC | 08/02/2007SE |
| K063159 | Sterilox Liquid Chemical Sterilant SystemMED · Traditional | Puricore, Inc. | 04/02/2007SE |
| K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…MED · Traditional | Advanced Infusion, Inc. | 07/03/2006SE |
| K060618 | Cidex Activated Dialdehyde SolutionMED · Special | Johnson & Johnson Co. | 04/12/2006SE |
| K041984 | Acecide High-Level Disinfectant and SterilantMED · Traditional | Best Sanitizers, Inc. | 05/11/2005SE |
| K041360 | Aldahol III High-Level DisinfectantMED · Traditional | Healthpoint, Ltd. | 05/05/2005SE |
| K032959 | Cidex Opa ConcentrateMED · Traditional | Advanced Sterilization Products | 04/04/2005SE |
| K033381 | Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate…MED · Traditional | Discus Dental, Inc. | 01/27/2004SE |
| K012889 | Banicide Liquid Chemical Sterilant/High-Level DisinfectantMED · Traditional | Pascal Co., Inc. | 05/27/2003SE |
| K030004 | 0.55% Orth-Phthalaldehyde SolutionMED · Traditional | Advanced Sterilization Products | 02/27/2003SE |
| K013280 | Sterilox Liquid Chemical Sterilant SystemMED · Traditional | Sterilox Technologies, Inc. | 09/18/2002SE |
| K003087 | Modification to Sporicidin Sterilizing and Disinfecting SolutionMED · Traditional | Sporicidin Intl. | 11/07/2000SE |
| K002401 | Cidex Opa Solution (0.55% Orthro-Phthalaldehyde Solution)MED · Special | Advanced Sterilization Products | 08/29/2000SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | Medivators, Inc. | 08/17/2000SE |
| K001381 | Cidex Opa SolutionMED · Special | Advanced Sterilization Products | 05/17/2000SE |
| K991487 | Cidex Opa SolutionMED · Traditional | Advanced Sterilization Products | 10/08/1999SE |
| K972708 | Endo-Spor Plus / HyprocideMED · Traditional | Cottrell, Ltd. | 09/13/1999SE |
| K984270 | Vapo-Solution for Use in MDT Harvey Chemiclave Sterilizers, Models 5000, 5500, and 6000MED · Traditional | Roger L. Goodman, D.D.S., P.C. | 05/20/1999SE |
| K990703 | Sporox II Sterilizing & Disinfecting SolutionMED · Special | Reckitt Benckiser, Inc. | 03/30/1999SE |
| K983194 | Sporicidin Sterilizing and Disinfecting Solution (SSDS)MED · Traditional | Sporicidin Intl. | 03/05/1999SE |
| K974188 | Cetylcide-GMED · Traditional | Kellerandheckman | 09/10/1998SE |
| K974062 | Medsci 3% GlutaraldehydeMED · Traditional | Medsci, Inc. | 09/02/1998SE |
| K962959 | Peracidin Dialyzer Reprocessing ConcentrateMED · Traditional | Hdc Medical, Inc. | 06/05/1998SE |
| K970726 | VapocideMED · Traditional | Cottrell, Ltd. | 05/18/1998SE |
| K961289 | VapopheneMED · Traditional | Germiphene Corp. | 12/04/1997SE |
| K970230 | SporoxMED · Traditional | Reckitt Benckiser, Inc. | 10/29/1997SE |
| K960513 | Peract 20 Liquid SterilantMED · Traditional | Minntech Corp. | 10/01/1997SE |
| K914749 | Wavicide(R) -01MED · Traditional | Wave Energy Systems, Inc. | 08/10/1995SE |
| K932922 | Procide 14 N.S., Omnicide/Liquid & Plus Liq ActivatorMED · Traditional | Cottrell, Ltd. | 07/03/1995SE |
| K931592 | Metricide Plus 30 Liquid Chemical GermicideMED · Traditional | Metrex Research Corp. | 12/06/1994SE |
| K931052 | Metricide 28MED · Traditional | Metrex Research Corp. | 12/06/1994SE |
| K930284 | MetricideMED · Traditional | Metrex Research Corp. | 12/06/1994SE |
| K932047 | Wavicide Monitor StripsMED · Traditional | Serim Research Corp. | 06/02/1994SE |
| K924334 | Cidex Formula 7* Long-Life Activated DialdehydeMED · Traditional | Johnson & Johnson Medical, Inc. | 03/29/1994SE |
| K932740 | Homepump NSFMED · Traditional | Block Medical, Inc. | 10/06/1993SE |
| K915170 | Pymah Cold Sterilog Glutaraldehyde MonitorMED · Traditional | Pymah Corp. | 07/28/1992SE |
| K913943 | Serim Disintek Reagent StripsMED · Traditional | Serim Research Corp. | 03/26/1992SE |
| K875280 | Steris System 1 Processor and 20 SterilantMED · Traditional | Steris C/O Medical Device Consultants, Inc. | 09/13/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1614-2022 Class II | a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800.…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1605-2022 Class II | STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-1721-2019 Class II | Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting SolutionImmersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. | Kerr/Pentron, DBA Kerr Corporation and… | 07/13/2018Terminated |
| Z-2714-2016 Class II | Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in…Certain lots of the acid solution in Acecide-C are degrading faster than normal. | Best Sanitizers Inc | 08/02/2016Terminated |
| Z-1180-2016 Class II | Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and…The firm discovered that one of the hysteroscope models listed for processing in four existing Quick… | Steris Corporation | 12/04/2015Terminated |
| Z-2774-2015 Class II | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat…Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings… | Advanced Sterilization Products | 08/10/2015Terminated |
| Z-2459-2015 Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may… | Advanced Sterilization Products | 07/27/2015Terminated |
| Z-1596-2013 Class II | Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH…During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to… | Steris Corporation | 03/04/2013Terminated |
| Z-2284-2012 Class II | QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray…STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to… | Steris Corporation | 08/10/2012Terminated |
| Z-2335-2012 Class II | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant…The firm initiated a recall after complaint investigations revealed that when the units are left on and not… | Steris Corporation | 08/01/2012Terminated |
| Z-2276-2012 Class II | CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55%…The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels… | Advanced Sterilization Products | 06/01/2012Terminated |
| Z-0869-2012 | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k)…Software deficiency. STERIS identified that water specifications were not being met at some of their… | Steris Corporation Hopkins Facility | 12/07/2011Terminated |
| Z-1960-2011 | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid…The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing… | Steris Corporation Hopkins Facility | 03/14/2011Terminated |
| Z-2462-2008 | Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724…During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter… | Steris Corp | 08/04/2008Terminated |
| Z-1190-2008 | Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor…Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may… | Steris Corp | 02/19/2008Terminated |
| Z-0101-2008 | Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes…Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out… | Steris Corporation Hopkins Facility | 09/12/2007Terminated |
| Z-0057-2008 | ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model…Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker… | I-Flow Corporation | 03/27/2007Terminated |
| Z-0967-2007 | Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes.…The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may… | Steris Corp | 02/23/2007Terminated |