Atlas FDA

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

3M Medical Products Group — Predicate Candidate Screening

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

89 daysmedian FDA review time
183 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K9714443M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES3M Medical Products Group1997-06-11510
K9551033M NO STING BARRIER FILM3M Medical Products Group1996-02-05890
K9521213M RESIN CEMENT3M Medical Products Group1995-06-22480
K9457263M(TM) EAR IMPRESSION MATERIAL3M Medical Products Group1995-01-27660
K9417183M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD3M Medical Products Group1994-10-071830
K9343333M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE3M Medical Products Group1994-07-073030
K9232223M COLOR LASER IMAGER, MODEL 9793M Medical Products Group1992-09-30910
K9230753M LASER IMAGER MODEL 9693M Medical Products Group1992-09-23900
K911252PRECISE BARND PI DISPOSABLE SURGICAL STAPLES3M Medical Products Group1991-07-251260
K9122253M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT3M Medical Products Group1991-07-22630
K9100923M LASER IMAGER XL3M Medical Products Group1991-04-08890
K910897PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X3M Medical Products Group1991-04-01280

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