LRTClass II
Indicator, Sterilization
General Hospital · 21 CFR 880.2800
MDR events10All time
Recalls1All time
Registered firms2Currently listed
510(k) clearances5All time
Recent MDR events
10 adverse event reports on file
- SINGLE USE PAPER FILTER WITH INDICATORDec 23, 2025MalfunctionAesculap Ag9610612-2025-00299
- SINGLE USE PAPER FILTER WITH INDICATORDec 23, 2025MalfunctionAesculap Ag9610612-2025-00300
- SINGLE USE PAPER FILTER WITH INDICATORNov 21, 2025MalfunctionAesculap Ag9610612-2025-00287
- INDICATOR, STERILIZATIONSep 10, 2025InjuryUnknownMW5175818
- CARD,LOAD RECORD,STERILIZATIONJun 20, 2023InjuryMedline Industries Lp1417592-2023-00253
- CARD,LOAD RECORD,STERILIZATIONJun 20, 2023InjuryMedline Industries Lp1417592-2023-00254
- CARD,LOAD RECORD,STERILIZATIONJun 20, 2023InjuryMedline Industries, Lp1417592-2023-00255
- CARD,LOAD RECORD,STERILIZATIONJun 20, 2023InjuryMedline Industries Lp1417592-2023-00256
- QUALI-QUICK TESTERMay 15, 1998MalfunctionMedical Products, Inc.MW4002216
- STERILIZATION INDICATOR STRIPSep 16, 1996MalfunctionSurgicot, Inc.MW4001495
Event type breakdown
Injury5
Malfunction5
Recalls
1 recall events for this product code
Registered firms
2 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Albert Browne , Ltd.Nov 5, 2001
K002937 · TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
- Albert Browne , Ltd.Sep 19, 1997
K965154 · TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
- Steritec Products Mfg Co, Inc.Aug 19, 1996
K951113 · CROSS-CHECKS
- Products For MedicineJun 28, 1995
K951703 · TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
- Propper Mfg. Co., Inc.Jun 1, 1987
K871672 · STERILIZATION INDICATOR FOR FLASH STERILIZATION