Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800) → LRT — Indicator, Sterilization

# LRT · Indicator, Sterilization

_General Hospital · 21 CFR 880.2800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT

## Overview

- **Product Code:** LRT
- **Device Name:** Indicator, Sterilization
- **Regulation:** [21 CFR 880.2800](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2800)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)
- **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](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K002937.md) | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | Nov 5, 2001 | SESE |
| [K965154](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K965154.md) | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | Sep 19, 1997 | SESE |
| [K951113](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K951113.md) | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | Aug 19, 1996 | SESE |
| [K951703](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K951703.md) | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | Products For Medicine | Jun 28, 1995 | SESE |
| [K871672](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT/K871672.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/LRT)

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