Atlas FDA

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

Omnisonics Medical Technologies · Predicate Candidate Screening

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

82 daysmedian FDA review time
97 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMOmnisonics Medical Technologies2008-12-15330
K071762OMNIWAVE ENDOVASCULAR SYSTEMOmnisonics Medical Technologies2007-09-27900
K052428RESOLUTION ENDOVASCULAR SYSTEMOmnisonics Medical Technologies2005-12-08970
K041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2Omnisonics Medical Technologies2004-09-01700
K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIOmnisonics Medical Technologies2001-03-08870
K993628OMNISONICS ULTRASONIC PROBESOmnisonics Medical Technologies1999-12-15490
K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical Technologies1999-12-06550
K991377OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLEROmnisonics Medical Technologies1999-07-12820

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