Product code FRC
- Device name
- Indicator, Biological Sterilization Process
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2800
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | 2026-04-08 |
| K252680 | Celerity™ 20 HP Biological Indicator | STERIS Corporation | 2025-09-24 |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | 2025-08-04 |
| 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 | 2025-06-06 |
| K250061 | Celerity Incubator | STERIS Corporation | 2025-02-06 |
| 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 | 2025-02-06 |
| 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 | 2025-01-28 |
| 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. | 2024-12-12 |
| 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 | 2024-11-25 |
| 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 | 2024-10-18 |
| 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 (C... | Terragene S.A. | 2024-09-18 |
| 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 | 2024-09-12 |
| K241542 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | 2024-06-27 |
| K240717 | 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | 2024-06-27 |
| 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 | 2024-03-15 |
| K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | 2023-12-15 |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation | 2023-08-07 |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | 2023-06-15 |
| K223715 | Celerity Incubator | STERIS Corporation | 2023-06-15 |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-05-09 |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | Terragene S.A. | 2023-02-28 |
| K213881 | Celerity Incubator | STERIS Corporation | 2022-07-21 |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2022-06-28 |
| K213296 | Anprolene SteriTest RRBI | Andersen Sterilizers, Inc. | 2022-04-12 |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader | 3M Company | 2022-04-06 |
| K220473 | CELERITY 20 HP Challenge Pack | Steris | 2022-03-18 |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2021-10-22 |
| K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | 2021-03-24 |
| K202879 | EOGas 4 Endo-SteriTest RRBI | Andersen Sterilizers, Inc. | 2021-03-03 |
| K210277 | 3M Attest Rapid Readout Biological Indicator, 1295 | 3M Company | 2021-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07798375773607 | BIOTRACE™ | TERRAGENE S.A. | 2026-03-10 |
| 07798164670209 | Bionova® | TERRAGENE S.A. | 2025-10-16 |
| 07798164673545 | Bionova® | TERRAGENE S.A. | 2025-10-16 |
| 07798375773539 | ProEdge | TERRAGENE S.A. | 2025-10-16 |
| 07798164670070 | Bionova® | TERRAGENE S.A. | 2025-10-16 |
| 07798375773034 | BIOTRACE™ | TERRAGENE S.A. | 2025-03-06 |
| 07798375772983 | BIOTRACE™ | TERRAGENE S.A. | 2024-11-12 |
| 07798375772945 | BIOTRACE™ | TERRAGENE S.A. | 2024-11-12 |
| 07798375772624 | BIOTRACE™ | TERRAGENE S.A. | 2024-11-12 |
| 07798375772327 | BIOTRACE™ | TERRAGENE S.A. | 2023-11-13 |
| 07798375772310 | BIOTRACE™ | TERRAGENE S.A. | 2023-11-13 |
| 07798164677727 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677758 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677512 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164677437 | Tuttnauer® | TERRAGENE S.A. | 2022-03-24 |
| 07798164679813 | Bionova® | TERRAGENE S.A. | 2022-03-22 |
| 07798164673941 | Bionova® | TERRAGENE S.A. | 2022-03-22 |
| 07798164677505 | Tuttnauer® | TERRAGENE S.A. | 2022-03-21 |
| 07798164677444 | Tuttnauer® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675440 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164675280 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164674252 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164673651 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164670247 | Bionova® | TERRAGENE S.A. | 2022-03-21 |
| 07798164679530 | Bionova® | TERRAGENE S.A. | 2022-01-17 |
| 07798164675211 | Bionova® | TERRAGENE S.A. | 2022-01-17 |
| 08800066500191 | STERLINK™ | Plasmapp Co.,Ltd. | 2021-11-26 |
| 08800066500207 | STERLINK™ | Plasmapp Co.,Ltd. | 2021-11-26 |
| 07798164678793 | Stryker | TERRAGENE S.A. | 2021-01-08 |
| 07798164675860 | Bionova® | TERRAGENE S.A. | 2021-01-04 |