Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

3M Company — Predicate Candidate Screening

331 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

65 daysmedian FDA review time

196 days90th percentile

331clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243501	3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge	3M Company	2025-01-28	77	0
K242538	3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3	3M Company	2024-11-25	91	0
K241959	3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD)	3M Company	2024-10-18	107	0
K241710	3M™ Attest™ Super Rapid Readout Biological Indicator 1492V;	3M Company	2024-09-12	90	0
K241542	3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Ch	3M Company	2024-06-27	27	0
K240717	3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™	3M Company	2024-06-27	104	0
DEN230068	3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-D	3M Company	2024-05-21	235	0
K233814	3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Ch	3M Company	2024-03-15	106	0
K222578	3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contain	3M Company	2023-05-18	266	0
K222508	3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248	3M Company	2022-11-01	75	0
K222152	3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228	3M Company	2022-09-23	65	0
K211705	3M Attest Rapid Readout Biological Indicator, 1295	3M Company	2022-06-28	390	0
K220942	3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE,	3M Company	2022-06-24	85	2
K220507	3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Devi	3M Company	2022-05-23	90	0
K220564	3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lea	3M Company	2022-05-23	84	0
K212022	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In	3M Company	2022-04-20	295	0
K213809	3M Attest Super Rapid Steam Biological Indicator, 3M Attest	3M Company	2022-04-06	121	0
K212081	3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	3M Company	2021-09-05	65	0
K210605	3M Bair Hugger Universal Warming Gown made with Thinsulate I	3M Company	2021-04-29	59	0
K210603	3M Bair Hugger Temperature Management System (Model 675)	3M Company	2021-03-30	29	0
K210277	3M Attest Rapid Readout Biological Indicator, 1295	3M Company	2021-03-03	30	0
K203458	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	2020-12-11	17	0
K200996	3M Attest Rapid Readout Biological Indicator	3M Company	2020-12-11	239	0
K203285	3M Comply Hydrogen Peroxide Indicator Tape 1228	3M Company	2020-12-10	31	0
K203284	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In	3M Company	2020-12-07	28	0
K200299	Curos Jet Disinfecting Cap	3M Company	2020-10-29	266	0
K200835	3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad	3M Company	2020-09-04	157	1
K200766	3M Attest Steam Chemical Integrator Test Pack	3M Company	2020-07-02	99	0
K192550	3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3	3M Company	2020-06-05	262	0
K193154	3M Attest Super Rapid 5 Steam-Plus Challenge Pack	3M Company	2020-02-07	85	2
K193254	3M Attest Steam Chemical Integrator	3M Company	2019-12-23	27	0
K191236	3M™ Attest™ Steam Chemical Integrators	3M Company	2019-11-22	198	0
K192937	3M Comply Hydrogen Peroxide Chemical Indicator	3M Company	2019-11-16	29	0
K192673	3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228	3M Company	2019-10-28	32	0
K192119	3M Clarity Aligners	3M Company	2019-09-05	30	0
K183211	3M Comply Hydrogen Peroxide Chemical Indicator	3M Company	2019-02-26	99	0
K183209	3M Comply Hydrogen Peroxide Indicator Tape	3M Company	2019-02-15	88	0
K183159	3M Clarity Aligners	3M Company	2018-11-26	11	0
K173519	3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attes	3M Company	2018-04-23	160	1
K173437	3M Attest Super Rapid Readout Biological Indicator 1492V, 3M	3M Company	2018-03-19	136	1
K173435	3M Attest Rapid Readout Biological Indicator	3M Company	2018-02-09	98	0
K173584	3M Attest Super Rapid Readout Biological Indicator, 3M Attes	3M Company	2018-01-22	63	0
K171373	3M Bair Hugger Model 675 Total Temperature Management System	3M Company	2017-10-10	153	0
K170321	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	2017-08-14	194	0
K170563	3M Comply Hydrogen Peroxide Indicator Tape	3M Company	2017-07-27	150	0
K171003	3M Attest Rapid Readout Biological Indicator, 3M Attest Auto	3M Company	2017-07-21	108	0
K171908	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dres	3M Company	2017-07-11	15	1
K153410	3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dres	3M Company	2017-05-15	537	1
K170330	3M Protemp Cement Temporary Dental Cement	3M Company	2017-02-06	4	0
K163207	Filtek One Bulk Fill Restorative	3M Company	2016-11-28	13	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda