Panels › General Hospital › Product code JOJ · Class 2
Indicator, Physical/Chemical Sterilization Process
Regulation 880.2800
4510(k)s in 12 months (266 all time)
0recalls in 12 months (24 all time)
19recalls that name a 510(k)
Top companies in JOJ
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 42 | 3 |
| 3M Company | 24 | 0 |
| Spsmedical Supply Corp. | 17 | 0 |
| Albert Browne , Ltd. | 16 | 0 |
| Steritec Products Mfg Co, Inc. | 16 | 0 |
| Advanced Sterilization Products | 8 | 5 |
| Propper Mfg. Co., Inc. | 11 | 1 |
| Serim Research | 12 | 0 |
| Steritec Products, Inc. | 12 | 0 |
| Dana Products, Inc. | 6 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2024 | TERRAGENE S.A. Terragene Integron IT26-C
Terragene Integron IT26-C with extender
Benco Dental Chemical Integrator [5726-583]
Tuttnauer (WTL198-0082)
Terragene Integron (PCD26-C)
Terragene Bionova PCD (PCD222-C) Open, Classified |
JOJ | K191021 |
| May 18, 2023 | 3M Company - Health Care Business 3M Attest Steam Chemical Integrators, REF 1243B Open, Classified |
JOJ | K220942 |
| May 18, 2023 | 3M Company - Health Care Business 3M Attest Steam Chemical Integrators, REF 1243A Open, Classified |
JOJ | K220942 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248.
b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348. Open, Classified |
JOJ | K101528 K193110 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250.
b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilizati Open, Classified |
JOJ | K020409 K890759 |
| Aug 10, 2022 | Steris Corporation Hopkins Facility Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design. Terminated |
JOJ | K162758 |
| Dec 29, 2021 | Young Dental Mfg Co I LLC YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312
Intended for use by a health care provider to accompany products being sterilized through a sterilizatio Open, Classified |
JOJ | K890761 |
| Jun 17, 2020 | Resource Optimization & Innovation LLC regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of s Terminated |
JOJ | K982188 |
| Mar 10, 2014 | Steris Corporation VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600.
The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads proces Terminated |
JOJ | K103053 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE
SteriTec Steam Biological Test Packs with Instant Readout Inte Terminated |
JOJ | K001444 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR
SteriTec Steam Biological Test Packs with Instant Readout Integrat Terminated |
JOJ | K001444 |
| Aug 22, 2011 | Steris Corporation Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Terminated |
JOJ | None listed |
| Aug 22, 2011 | Steris Corporation Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Pa Terminated |
JOJ | None listed |
| Apr 29, 2010 | Steritec Products Mfc. Co., Inc. Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205. Terminated |
JOJ | K972300 |
| Apr 29, 2010 | Steritec Products Mfc. Co., Inc. Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238. Terminated |
JOJ | K024293 K083650 |
| Sep 20, 2008 | Propper Mfg Co Inc Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101 Terminated |
JOJ | None listed |
| Aug 8, 2008 | 3M Company / Medical Division 3M Comply EO Chemical Indicators Strips, Catalog #1251
The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical i Terminated |
JOJ | None listed |
| Oct 11, 2006 | 3M Company / Medical Division 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. Terminated |
JOJ | K013228 |
| Apr 27, 2005 | Advanced Sterilization Products Cidexplus Solution Test Strips Terminated |
JOJ | K981054 |
| Sep 21, 2004 | Advanced Sterilization Products Ortho-phthaladehyde Concentration Indicator
Browne CIDEX OPA Indicator Terminated |
JOJ | K991709 |
| Sep 21, 2004 | Advanced Sterilization Products Gluteraldehyde Concentration Indicators
''Browne GA Indicator for CIDEX Products'' Terminated |
JOJ | K922481 |
| Sep 21, 2004 | Advanced Sterilization Products Gluteraldehyde Concentration Indicators
''Browne GA Indicator for CIDEX PLUS Products'' Terminated |
JOJ | K981054 |
| Jan 29, 2004 | Advanced Sterilization Products Cidex Plus Test Strips Terminated |
JOJ | None listed |
| Apr 9, 2003 | Sybron Dental Specialties Gluteraldehyde Concentration Indicators.
MetriTest 1.5% and MetriTest 1.8%, also
OmniChek 1.5% and OmniCheck 1.8% Terminated |
JOJ | K922481 |
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