510(k) K250044
- Device
- Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
- Applicant
- STERIS Corporation
- 510(k) number
- K250044
- Product code
- FRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-06
- Date received
- 2025-01-10
- Regulation
- 880.2800
- Classification name
- Indicator, Biological Sterilization Process
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Logan Persons
- Address
- 5960 Heisley Rd. Mentor OH US 44060 44060
FDA Registration Numbers
- 3009968482
- 3000251274
- 3016075971
- 3007412809
- 3030733800
- 3036504234
- 3015392401
- 2434982
- 3014421917
- 3004634710
- 2029076
- 1416605
- 3009609218
- 3004080920
- 3011061109
- 2028456
- 3012494290
- 3030626857
- 3013145340
- 3003476474
- 2410251
- 2432141
- 3012421607
- 3017524825
- 3013667284
- 3016678045
- 3043226252
- 3012723641
- 1319130
- 3031757047
- 1720309
- 3042272797
- 8030087
- 3013557562
- 2183301
- 3038718579
- 9611959
- 3014579161
- 3031841433
- 2084725
- 3013298431
- 2133641
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code FRC
| 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 |
| 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 (CT40) | 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 |