Atlas FDA

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

Omnitron Intl., Inc. — Predicate Candidate Screening

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

115 daysmedian FDA review time
966 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K901615PULMOCATH INTRABRONCHIAL CATHETEROmnitron Intl., Inc.1992-11-279660
K923130IR-192 IMPLANT -- MODIFICATIONOmnitron Intl., Inc.1992-09-21880
K920431OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGEOmnitron Intl., Inc.1992-05-291160
K913908OMNITRON GYN APPLICATOR SYSTEMOmnitron Intl., Inc.1992-03-061890
K915253IR-192 IMPLANT, MODIFICATIONOmnitron Intl., Inc.1992-02-271010
K911775OMNICATH IMPLANTED CATHETER AND DEPOTOmnitron Intl., Inc.1991-05-08370
K881665OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOROmnitron Intl., Inc.1988-08-111150

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