FRC
- Product code
- FRC
- Device name
- Indicator, Biological Sterilization Process
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.2800
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 206 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260766 | 2026-04-08 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052) | |
| K252680 | 2025-09-24 | STERIS Corporation | Celerity 20 HP Biological Indicator | |
| K251122 | 2025-08-04 | Terragene | Terragene® Bionova® BT20 Biological Indicator | |
| K251452 | 2025-06-06 | Steris | Celerity 5 HP Biological Indicator (LCB052); Celerit… | |
| K250044 | 2025-02-06 | STERIS Corporation | Celerity 5 HP Biological Indicator (LCB052); Celerit… | |
| K250061 | 2025-02-06 | STERIS Corporation | Celerity Incubator | |
| K243501 | 2025-01-28 | 3M Company | 3M Attest Super Rapid Steam Extended Cycle Clear C… | |
| K242453 | 2024-12-12 | Terragene S.A. | Terragene® Bionova® Photon Process Challenge Device … | |
| K242538 | 2024-11-25 | 3M Company | 3M Attest Super Rapid Readout Biological Indicator… | |
| K241959 | 2024-10-18 | 3M Company | 3M Attest Super Rapid Steam Clear Challenge Pack (… | |
| K231383 | 2024-09-18 | Terragene S.A. | Terragene® Bionova® Self-Contained Biological Indica… | — |
| K241710 | 2024-09-12 | 3M Company | 3M Attest Super Rapid Readout Biological Indicator… | |
| K240717 | 2024-06-27 | 3M Company | 3M Attest Rapid Readout Biological Indicator 1295 … | |
| K241542 | 2024-06-27 | 3M Company | 3M Attest Super Rapid Vaporized Hydrogen Peroxide … | |
| K233814 | 2024-03-15 | 3M Company | 3M Attest Super Rapid Vaporized Hydrogen Peroxide … | |
| K233681 | 2023-12-15 | STERIS Corporation | ConFirm 20 Minute Incubator |
Official FDA classification page: FRC
Classification and pathway per current FDA publications. Data from openFDA (CC0).