Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Zonare Medical Systems, Inc. · Predicate Candidate Screening

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

36 daysmedian FDA review time
67 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.2015-05-15140
K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.2015-03-04290
K141641ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEMZonare Medical Systems, Inc.2014-07-18290
K120703ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEMZonare Medical Systems, Inc.2012-04-13360
K101091Z.ONE ULTRA ULTRASOUND SYSTEMZonare Medical Systems, Inc.2010-06-25670
K082326ZONARE ULTRA ULTRASOUND SYSTEMZonare Medical Systems, Inc.2008-10-08550

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