Atlas FDA

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

Zcv ,Inc. · Predicate Candidate Screening

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

139 daysmedian FDA review time
373 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K010099ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETERZcv ,Inc.2001-02-01210
K002603ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATZcv ,Inc.2001-01-081390
K003118Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODZcv ,Inc.2000-12-20760
K002481ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-XZcv ,Inc.2000-12-071150
K991060ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000Zcv ,Inc.2000-04-063730
K990689ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9Zcv ,Inc.1999-09-031840

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