Atlas FDA

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

FCK — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

97 daysmedian FDA review time
198 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc.2017-04-064630
K103326MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.2011-04-061450
K062159RB12 SUCTION RECTAL BIOPSY SYSTEMAus Systems Pty , Ltd.2006-09-05390
K061201DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 0071United States Endoscopy Group, Inc.2006-05-30290
K051637DSNARE, MODEL 00711087United States Endoscopy Group, Inc.2005-10-311330
K954693MEHTA BRONCHIAL BIOSPY DRILLUnited States Endoscopy Group, Inc.1995-10-23120
K944252BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.1994-12-05970
K932142SUCTION GUILLOTINE DEVICETriton Technology, Inc.1993-09-241440
K911448MULTIPLE BIOPSY DEVICE-MBXTriton Technology, Inc.1991-04-16320
K902910CYTOASPIRATORH & B Medical Technology, Inc.1991-01-161980
K902097MODEL TR RECTAL SUCTION BIOPSY TUBEMedical Measurements, Inc.1990-07-27800
K895420SUCTION BIOPSY INSTRUMENTMill-Rose Laboratory1990-02-091610
K895900WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLEWilson-Cook Medical, Inc.1990-01-11970

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