FRC — Indicator, Biological Sterilization Process Class II
FDA product code FRC covers "Indicator, Biological Sterilization Process", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260766 | steris corporation | Celerity 5 HP Biological Indicator (LCB052) | April 8, 2026 |
| 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 |
| K250061 | steris corporation | Celerity Incubator | February 6, 2025 |
| K250044 | steris corporation | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 | 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 |
| K241542 | 3m | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD | June 27, 2024 |
| K240717 | 3m | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hy | 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 |
| K223715 | steris corporation | Celerity Incubator | June 15, 2023 |
| K223717 | steris corporation | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | June 15, 2023 |
| K223023 | plasmapp co | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD | May 9, 2023 |