Atlas FDA

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

Marine Polymer Technologies, Inc. — Predicate Candidate Screening

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

123 daysmedian FDA review time
267 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160695Talymed SuspensionMarine Polymer Technologies, Inc.2016-12-062670
K111524MP 719Marine Polymer Technologies, Inc.2011-07-22500
K082703MRDH BANDAGEMarine Polymer Technologies, Inc.2008-10-14280
K070557MP 719Marine Polymer Technologies, Inc.2007-05-23850
K053300SYVEKEXCELMarine Polymer Technologies, Inc.2006-03-281230
K002550RDH BANDAGEMarine Polymer Technologies, Inc.2000-12-201250
K984177MODIFICATION TO SKVEKPATCHMarine Polymer Technologies, Inc.1998-12-18280
K972914SYVEK PATCHMarine Polymer Technologies, Inc.1997-12-221370

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