Atlas FDA

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

MND — Predicate Candidate Screening

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

87 daysmedian FDA review time
286 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132535AUTOBAND LIGATOREndochoice, Inc.2013-08-23100
K083556MODIFICATION TO AUTO-BAND LIGATORScandimed International2009-02-19790
K081142AUTO-BAND LIGATORScandimed International2008-05-16240
K051950INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321Ethicon Endo-Surgery, Inc.2005-10-07810
K031236AUTO-BAND LIGATORScandimed. A.S.2003-11-142100
K033245BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, Inc.2003-11-06300
K022434BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, Inc.2002-08-05110
K013066HX-5/6-1 ENDOSCOPIC CLIPPING DEVICEOlympus America, Inc.2001-12-11901
K001744OLYMPUS ENDOSCOPIC LIGATION DEVICEOlympus America, Inc.2001-02-272640
K990864SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228Boston Scientific Corp1999-06-11870
K984255OLYMPUS HX-20 SERIES LIGATING DEVICEOlympus Corp of America1999-01-12430
K964661HX-20/21-1 ENDOSCOPIC LIGATOROlympus America, Inc.1997-10-303440
K971137BARD RAPIDFIRE MULTIPLE BAND LIGATORC.R. Bard, Inc.1997-10-162020
K944220WILSON COOK MULTIPLE BAND LIGATORWilson-Cook Medical, Inc.1995-01-241482
K940661STIEGMANN-GOFF ENDOSCOPIC LIGATORC.R. Bard, Inc.1994-11-282860

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