# 3M Healthcare

- Location (FDA's records): St. Paul, MN
- FDA decisions: 21 (1991–2020): 21 510(k) clearances
- Product codes: KKX (4), DRX (2), DWF (2), FXX (2), DRY (2), GEI (2), MSH (1), MGP (1), HRX (1), KMF (1), QKM (1), NJM (1)
- 510(k) review time since 2016: median 113 days, against 119 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 24 (0 its own); citations of its devices by later devices: 25 (0 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Health Care, Sarns: 10 (https://510kreport.com/company/3m-health-care-sarns)
- 3M Company: 4 (https://510kreport.com/company/3m)
- 3M Health Care, Ltd.: 3 (https://510kreport.com/company/3m-health-care)
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)
- Halyard Health, Inc.: 1 (https://510kreport.com/company/halyard-health)
- Atrium Medical Corp.: 1 (https://510kreport.com/company/atrium-medical)
- 3M Medical Products Group: 1 (https://510kreport.com/company/3m-medical-products-group)
- Advanced Medical Solutions (Plymouth), Ltd.: 1 (https://510kreport.com/company/advanced-medical-solutions-plymouth)

## Firms that cite its devices most
- 3M Company: 3 (https://510kreport.com/company/3m)
- Covalontechnologies, Inc.: 3 (https://510kreport.com/company/covalontechnologies)
- United Sewing Automation, Inc.: 1 (https://510kreport.com/company/united-sewing-automation)
- Unicoglobal, Inc.: 1 (https://510kreport.com/company/unicoglobal)
- Orbital Research, Inc.: 1 (https://510kreport.com/company/orbital-research)
- Qiqihar Hengxin Medical Supplies, Ltd.: 1 (https://510kreport.com/company/qiqihar-hengxin-medical-supplies)
- Changzhou Combat Protective Equipment Co., Ltd.: 1 (https://510kreport.com/company/changzhou-combat-protective-equipment)
- Entrotech Life Sciences, Inc.: 1 (https://510kreport.com/company/entrotech-life-sciences)

## Its most-cited devices
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (2019), cited by 10
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres (1997), cited by 8
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape (2014), cited by 2
- K970796: 3M Red Dot 2560 & 2570 Monitoring Electrodes (1997), cited by 1
- K180874: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (2018), cited by 1
- K941388: 3M Fluid Irrigation System (1994), cited by 1

## Recent decisions
- K193110: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (Mar 13, 2020)
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (Sep 11, 2019)
- K180874: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (Jul 31, 2018)
- K180404: 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (Mar 16, 2018)
- K171116: 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (Aug 10, 2017)
- K153571: Cavilon Advanced High Endurance Skin Protectant (Aug 23, 2016)
- K140330: 3M Steri-Drape Fabric Surgical Drapes (Aug 18, 2014)
- K140250: 3M Steri-Drape CHG Antimicrobial Incise Drape (Jul 25, 2014)

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