510(k) K223715

Device: Celerity Incubator
Applicant: STERIS Corporation
510(k) number: K223715
Product code: FRC
Decision: Substantially Equivalent (SESE)
Decision date: 2023-06-15
Date received: 2022-12-02
Regulation: 880.2800
Classification name: Indicator, Biological Sterilization Process
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Gregoy Land
Address: 5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers

8030087
3036504234
2410251
3016678045
1720309
3013667284
9611959
3030733800
3011061109
3007412809
1319130
3031841433
3031757047
3038718579
3013298431
2434982
3017524825
3015392401
3009609218
3004080920
3004634710
3012723641
3014579161
2432141
3014421917
1416605
3013145340
2183301
2084725
3009968482
3016075971
3042272797
2028456
3003476474
3012494290
3012421607
3030626857
3013557562
2029076
3043226252
3000251274
2133641

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FRC

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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
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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