Atlas FDA

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

3M Deutschland GmbH · Predicate Candidate Screening

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

79 daysmedian FDA review time
220 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220257Permadyne3M Deutschland GmbH2022-02-0110
K192992Suglue 33M Deutschland GmbH2019-11-05110
K192961ADH193M Deutschland GmbH2019-10-3190
K173318Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH2017-10-31110
K161922XP2023M Deutschland GmbH2016-09-01500
K153174Ketac Universal Aplicap3M Deutschland GmbH2016-04-131620
K151748Clean & More3M Deutschland GmbH2016-03-112560
K151144SuPro 1003M Deutschland GmbH2015-09-141380
K140684CLINPRO PROPHY POWDER3M Deutschland GmbH2014-10-242200
K133436FLASH AR; FLASH AR QUICK3M Deutschland GmbH2014-03-071190
K131404FLASH AR PENTA / FLASH AR PENTA QUICK3M Deutschland GmbH2013-05-30150
K120438FLASH (DIFFERENT MATERIALS)3M Deutschland GmbH2012-05-02790

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