Atlas FDA

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

MKY · Predicate Candidate Screening

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

168 daysmedian FDA review time
227 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.2001-03-152270
K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.1998-09-08560
K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.1997-04-16700
K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.1997-01-142250
K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.1994-11-041680
K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, Inc.1994-07-19530

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