Atlas FDA

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

Omni Intl., Inc. · Predicate Candidate Screening

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

47 daysmedian FDA review time
70 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABOmni Intl., Inc.1999-01-13580
K984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEOmni Intl., Inc.1999-01-08530
K853255OMNIMED I.V. SOLUTION ADMIN. SETOmni Intl., Inc.1985-08-23210
K851938OMNIMED SURGICAL GOWNOmni Intl., Inc.1985-06-28560
K851654OMNIMED CLAMPOmni Intl., Inc.1985-05-31390
K851734OMNIMED SUPERIOR TRANSDUCER PROTECTOROmni Intl., Inc.1985-05-23280
K850706F-SERIES IMPLANTOmni Intl., Inc.1985-04-10470
K850112OMNIMED IV SOLUTION ADMINISTRATION SETOmni Intl., Inc.1985-02-22390
K850066OMNIMED NASAL OXYGEN CANNULAOmni Intl., Inc.1985-01-24160
K831147OMNIPROBE ELECTRICAL NERVE STIMULATOROmni Intl., Inc.1983-07-181010
K821523OMNI TENSOmni Intl., Inc.1982-06-16260
K813604OMNI STIM IIOmni Intl., Inc.1982-03-08700

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