Atlas FDA

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

Braun GmbH — Predicate Candidate Screening

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

33 daysmedian FDA review time
163 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061351ORAL-B SONIC COMPLETEBraun GmbH2006-06-05210
K061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESBraun GmbH2006-05-31330
K060006BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETERBraun GmbH2006-01-31280
K031928BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMEBraun GmbH2003-10-241230
K012035BRAUN PRECISION SENSOR PRO, MODEL BP 2590Braun GmbH2001-07-27280
K003732BRAUN PRECISION SENSOR, MODEL BP 2000 SERIESBraun GmbH2001-05-161630
K992468BRAUN THERMOSCAN PRO3000 INFARED THERMOMETERBraun GmbH1999-10-20890

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