FRC · Indicator, Biological Sterilization Process
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | FRC |
|---|---|
| Device Name | Indicator, Biological Sterilization Process |
| 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 (20 of 206)
Showing 20 most recent of 206 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | Apr 8, 2026 | SESE |
| K252680 | Celerity 20 HP Biological Indicator | STERIS Corporation | Sep 24, 2025 | SESE |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | Aug 4, 2025 | SESE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris | Jun 6, 2025 | SESE |
| K250061 | Celerity Incubator | STERIS Corporation | Feb 6, 2025 | SESE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation | Feb 6, 2025 | SESE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | Jan 28, 2025 | SESE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene S.A. | Dec 12, 2024 | SESE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | Nov 25, 2024 | SESE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company | Oct 18, 2024 | SESE |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | Sep 18, 2024 | SESE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | Sep 12, 2024 | SESE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | Jun 27, 2024 | SESE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | Jun 27, 2024 | SESE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company | Mar 15, 2024 | SESE |
| K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | Dec 15, 2023 | SESE |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation | Aug 7, 2023 | SESE |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | Jun 15, 2023 | SESE |
| K223715 | Celerity Incubator | STERIS Corporation | Jun 15, 2023 | SESE |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | May 9, 2023 | SESE |
Top Applicants
- STERIS Corporation — 33 clearances
- 3M Company — 31 clearances
- Advanced Sterilization Products — 17 clearances
- Raven Biological Laboratories, Inc. — 12 clearances
- Spsmedical Supply Corp. — 9 clearances
