Atlas FDA

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

Omega-Med Intl., Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time
224 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K842603OMED DISPOS. INSTRUMENT GUARDSOmega-Med Intl., Inc.1984-09-05620
K832441SUTURE-AID BOOTIESOmega-Med Intl., Inc.1984-03-052240
K830484OMED IDENT-I-BANDOmega-Med Intl., Inc.1983-03-24370
K822284COMPLY NEUROMUSCULAR STIMULATOROmega-Med Intl., Inc.1982-09-17490
K821334OMED FABRIC INSTRUMENT COVERS-RADIOPAQOmega-Med Intl., Inc.1982-05-24190
K813499OMED DISPOSABLE BULLDOGOmega-Med Intl., Inc.1981-12-29150
K810883OMED SILICONE INSTRUMENT COVERSOmega-Med Intl., Inc.1981-04-23220
K810260OMED SILICONE LOOPSOmega-Med Intl., Inc.1981-02-26270
K810269OMED FABRIC INSTRUMENT COVERSOmega-Med Intl., Inc.1981-02-26240

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