Atlas FDA

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

Kerecis Limited — Predicate Candidate Screening

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

173 daysmedian FDA review time
420 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited2025-07-16300
K251844Kerecis SurgiBind (50241)Kerecis Limited2025-07-15290
K243843Tendon Protect (50242)Kerecis Limited2025-06-041730
K241080Kerecis Parvus (50207)Kerecis Limited2024-08-211240
K213231Kerecis SiliconeKerecis Limited2022-06-292720
K202430Kerecis ReconstructKerecis Limited2021-05-022500
K192612Kerecis Gingiva GraftKerecis Limited2020-11-134200
K190528MariGen Wound ExtraKerecis Limited2019-07-101280
K153364Kerecis SecureMeshKerecis Limited2016-08-192730
K132343MARIGEN WOUND DRESSINGKerecis Limited2013-10-23850

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