Atlas FDA

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

KGW — Predicate Candidate Screening

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

77 daysmedian FDA review time
462 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260982Alexis lighted wound protector-retractor, flexible, extra smApplied Medical Resources Corporation2026-04-24300
K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CLApplied Medical Resources Corporation2026-02-231020
K113268ALEXIS O WOUND PROTECTOR/RETRACTORApplied Medical Resources Corp.2013-02-084620
K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORApplied Medical Resources Corp.2010-04-02770
K093296ALEXIS LAPAROSCOPIC SYSTEMApplied Medical Resources Corp.2009-11-05150
K062907ALEXIS WOUND RETRACTORApplied Medical Resources2007-01-091040
K041711ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, CApplied Medical Resources Corp.2004-08-26640
K840946MICROPOROUS HYPOALLERGENICGainor Medical1984-08-171650
K790306EDGE PROTECTOR, BARRIERSurgikos, Inc.1979-02-2290

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