LRT · Indicator, Sterilization
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | LRT |
|---|---|
| Device Name | Indicator, Sterilization |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | Nov 5, 2001 | SESE |
| K965154 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | Sep 19, 1997 | SESE |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | Aug 19, 1996 | SESE |
| K951703 | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | Products For Medicine | Jun 28, 1995 | SESE |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | Jun 1, 1987 | SESE |
Top Applicants
- Albert Browne , Ltd. — 2 clearances
- Products For Medicine — 1 clearance
- Propper Mfg. Co., Inc. — 1 clearance
- Steritec Products Mfg Co, Inc. — 1 clearance
