Atlas FDA

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

Medac, Inc. — Predicate Candidate Screening

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

71 daysmedian FDA review time
138 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874319MONITOR, ELECTROGRAPHICMedac, Inc.1988-03-071380
K874447DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELECMedac, Inc.1988-01-27910
K874090300M ECG MONITRO/TRANSCUTANEOUS PACEMAKERMedac, Inc.1987-12-15690
K874091360D DC DEFIBRILLATORMedac, Inc.1987-11-23470
K871176PACE 10 NON-INVASIVE EXTERNAL PACEMAKERMedac, Inc.1987-04-23300
K864985DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCEMedac, Inc.1987-03-10780
K864989ETP 180A NON-INVASIVE EXTERNAL PACEMAKERMedac, Inc.1987-03-03710
K864986ETP 300 NON-INVASIVE EXTERNAL PACEMAKERMedac, Inc.1987-03-03710
K864987DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCEMedac, Inc.1987-03-03710
K864988ETP 180E NON-INVASIVE EXTERNAL PACEMAKERMedac, Inc.1987-03-03710

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