Atlas FDA

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

3M Healthcare · Predicate Candidate Screening

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

118 daysmedian FDA review time
229 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In3M Healthcare2020-03-131221
K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Re3M Healthcare2019-09-111130
K1808743M High Performance Surgical Mask, 3M High Performance Surgi3M Healthcare2018-07-311190
K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated 3M Healthcare2018-03-16300
K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical M3M Healthcare2017-08-101180
K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare2016-08-232520
K1403303M STERI-DRAPE FABRIC SURGICAL DRAPES3M Healthcare2014-08-181890
K1402503M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE3M Healthcare2014-07-251750
K9744453M RED DOT RESTING EKG ELECTRODE, CATALOG 23603M Healthcare1998-07-262430
K9807323M CDI QUICK-CELLS WITH HEPARIN TREATMENT3M Healthcare1998-05-15790
K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL 3M Healthcare1998-02-03780
K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 3M Healthcare1998-01-30773
K9734723M CDI H/S CUVETTES WITH HEPARON TREATMENT3M Healthcare1997-12-08870
K9730363M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DR3M Healthcare1997-11-12900
K964374SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT3M Healthcare1997-06-182290
K964373SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT3M Healthcare1997-06-182290
K9707963M RED DOT 2560 & 2570 MONITORING ELECTRODES3M Healthcare1997-04-09361
K9460243M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS3M Healthcare1995-02-08610
K9460253M X-LARGE SHEET #7979/ #7979NS3M Healthcare1995-02-02550
K9413883M FLUID IRRIGATION SYSTEM3M Healthcare1994-10-071990
K9055393M 6830 ELECTRODE3M Healthcare1991-05-281680

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