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

Tracoe Medical GmbH · Predicate Candidate Screening

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

231 daysmedian FDA review time
453 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203362TRACOE varioTracoe Medical GmbH2021-08-052620
K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH2018-04-272310
K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH2016-12-214530
K152865TRACOE smart Cuff ManagerTracoe Medical GmbH2016-09-273630
K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: Tracoe Medical GmbH2005-10-251320
K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHTracoe Medical GmbH2005-02-18950
K961449TRACHEOSTOMY TUBES TRACOE-FLEXTracoe Medical GmbH1996-09-131500
K781729TRACHEOTOMY TUBESTracoe Medical GmbH1978-10-24140

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