510(k) Report

FDA applicant

3M Healthcare

St. Paul, MN21 decisions1991–202010 recalls

FDA records 21 decisions for 3M Healthcare (St. Paul, MN) from 1991 to 2020: 21 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and DRX (Electrode, Electrocardiograph). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 0 of them its own earlier devices. 10 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided 3M Healthcare’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2014: 22016: 12017: 12018: 22019: 12020: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2010: 12016: 12020: 52022: 22024: 1
2007high 5 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3M Healthcare by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3M Healthcare’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial4decisions
  • DRXElectrode, Electrocardiograph2decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • FXXMask, Surgical2decisions
  • DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Also: MSH (1), MGP (1), HRX (1), KMF (1), QKM (1), NJM (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare · 201910cite it
  • K9730363M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP…3M Healthcare · 19978cite it
  • K1402503M Steri-Drape CHG Antimicrobial Incise Drape3M Healthcare · 20142cite it
  • K9707963M Red Dot 2560 & 2570 Monitoring Electrodes3M Healthcare · 19971cites it
  • K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare · 20181cites it
  • K9413883M Fluid Irrigation System3M Healthcare · 19941cites it

What has FDA decided for it lately?

  • K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare · 20201 recall
  • K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare · 2019
  • K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare · 2018
  • K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System3M Healthcare · 2018
  • K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare · 2017
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
  • K1403303M Steri-Drape Fabric Surgical Drapes3M Healthcare · 2014
  • K1402503M Steri-Drape CHG Antimicrobial Incise Drape3M Healthcare · 2014

All 21 as 3M Healthcare →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K974279Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097DApr 8, 2024Class II
  • K9742793M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165May 25, 2022Class II
  • K193110a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M…May 25, 2022Class III
  • K9707963M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by…Sep 15, 2020Class II
  • K9707963M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Sep 15, 2020Class II
  • K9707963M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Sep 15, 2020Class II