# 3M Company

- Location (FDA's records): St. Paul, MN
- FDA decisions: 337 (1976–2025): 334 510(k) clearances, 2 De Novo grants and 1 original PMA approval
- Names in FDA's records: 3M Company (332); 3M (4); 3M Company Corp (1)
- Product codes: FRC (32), JOJ (25), EBF (18), ESD (16), DHB (13), EMA (12), FRO (10), FRN (8), DQD (6), FXX (6), KGX (6), GXY (5)
- 510(k) review time since 2016: median 91 days, against 106 for FDA's reviews in the same codes and years (30 of 44 faster)
- Predicates its devices cite: 137 (70 its own); citations of its devices by later devices: 251 (70 its own)
- Recalls linked to its devices: 91 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Health Care, Ltd.: 5 (https://510kreport.com/company/3m-health-care)
- 3M Company-3M Health Care: 5 (https://510kreport.com/company/3m-company-3m-health-care)
- 3M Espe Dental Products: 4 (https://510kreport.com/company/3m-espe-dental-products)
- Dentsply Intl.: 3 (https://510kreport.com/company/dentsply-intl)
- 3M Healthcare: 3 (https://510kreport.com/company/3m-healthcare)
- Kci USA, Inc.: 3 (https://510kreport.com/company/kci-usa)
- Scientific Pharmaceuticals, Inc.: 2 (https://510kreport.com/company/scientific-pharmaceuticals)
- Pymah Corp.: 2 (https://510kreport.com/company/pymah)

## Firms that cite its devices most
- 3M Espe Dental Products: 9 (https://510kreport.com/company/3m-espe-dental-products)
- Dmg USA, Inc.: 6 (https://510kreport.com/company/dmg-usa)
- 3M Espe AG Dental Products: 5 (https://510kreport.com/company/3m-espe-ag-dental-products)
- STERIS Corporation: 5 (https://510kreport.com/company/steris)
- 3M Healthcare: 4 (https://510kreport.com/company/3m-healthcare)
- Sharp Corporation: 3 (https://510kreport.com/company/sharp)
- U&U Medical Technology Co, Ltd.: 3 (https://510kreport.com/company/u-u-medical-technology)
- Nanova Biomaterials, Inc.: 3 (https://510kreport.com/company/nanova-biomaterials)

## Its most-cited devices
- K083903: 3M Littmann Electronic Stethoscope, Model 3200 (2009), cited by 17
- K083610: Filtek Supreme Ultra Universal Restorative (2008), cited by 11
- K100235: Filtek Supreme Ultra Flowable Restorative (2010), cited by 9
- K962785: 3M Dent System (1996), cited by 8
- K992326: 3M Clinpro Sealant (1999), cited by 7
- K031287: Steri-Drape Surgical Drapes (2003), cited by 7

## Recent decisions
- 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 (Jan 28, 2025)
- 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 (Nov 25, 2024)
- 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) (Oct 18, 2024)
- 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 (Sep 12, 2024)
- K240717: 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (Jun 27, 2024)
- K241542: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (Jun 27, 2024)
- DEN230068: 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 (May 21, 2024)
- 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) (Mar 15, 2024)

Source page: https://510kreport.com/company/3m