FRC — Indicator, Biological Sterilization Process Class II
FDA Device Classification
Classification Details
- Product Code
- FRC
- Device Class
- Class II
- Regulation Number
- 880.2800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252680 | steris corporation | Celerity 20 HP Biological Indicator | September 24, 2025 |
| K251122 | terragene | Terragene® Bionova® BT20 Biological Indicator | August 4, 2025 |
| K251452 | steris | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 | June 6, 2025 |
| K250044 | steris corporation | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 | February 6, 2025 |
| K250061 | steris corporation | Celerity Incubator | February 6, 2025 |
| K243501 | 3m | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M | January 28, 2025 |
| K242453 | terragene | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator | December 12, 2024 |
| K242538 | 3m | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rap | November 25, 2024 |
| K241959 | 3m | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-r | October 18, 2024 |
| K231383 | terragene | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono | September 18, 2024 |
| K241710 | 3m | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-rea | September 12, 2024 |
| K240717 | 3m | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hy | June 27, 2024 |
| K241542 | 3m | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD | June 27, 2024 |
| K233814 | 3m | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PC | March 15, 2024 |
| K233681 | steris corporation | ConFirm 20 Minute Incubator | December 15, 2023 |
| K231490 | steris corporation | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indica | August 7, 2023 |
| K223717 | steris corporation | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | June 15, 2023 |
| K223715 | steris corporation | Celerity Incubator | June 15, 2023 |
| K223023 | plasmapp co | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD | May 9, 2023 |
| K221641 | terragene | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper | February 28, 2023 |