Atlas FDA

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

Marina Medical Instruments, Inc. — Predicate Candidate Screening

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

194 daysmedian FDA review time
305 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042534MARINA MEDICAL FINGER PROTECTORSMarina Medical Instruments, Inc.2005-05-102350
K031463MARINA MEDICAL SILICONE PESSARYMarina Medical Instruments, Inc.2003-11-181940
K021876MAS WITH OR WITHOUT SYRINGEMarina Medical Instruments, Inc.2003-04-083050
K023725HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247Marina Medical Instruments, Inc.2003-02-03890
K010296UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450Marina Medical Instruments, Inc.2001-04-11700

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