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

Asap Endoscopic Products GmbH · Predicate Candidate Screening

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

95 daysmedian FDA review time
257 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121261ASAP MUITISCOPEAsap Endoscopic Products GmbH2013-01-082570
K032822ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0Asap Endoscopic Products GmbH2004-01-081200
K031974ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-0Asap Endoscopic Products GmbH2003-09-29950
K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00,Asap Endoscopic Products GmbH2003-09-15810
K031141ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OEAsap Endoscopic Products GmbH2003-06-30810

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