510(k) K243501

Device: 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
Applicant: 3M Company
510(k) number: K243501
Product code: FRC
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-28
Date received: 2024-11-12
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: N

Related Records

Applicant Contact

Contact: Michelle Larsen
Address: 3m Center 2510 Conway Ave., Bldg. 275-5w-06 St. Paul MN US 55144 55144

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

510(k) summary PDF

Other 510(k) Records For Product Code FRC

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K252680	Celerity 20 HP Biological Indicator	STERIS Corporation	2025-09-24
K251122	Terragene® Bionova® BT20 Biological Indicator	Terragene	2025-08-04
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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
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