Atlas FDA

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

Cardiac Resucitator Corp. · Predicate Candidate Screening

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

57 daysmedian FDA review time
151 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882513MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATORCardiac Resucitator Corp.1988-07-12400
K871971MODIFIED PACE*AID MODEL 53Cardiac Resucitator Corp.1987-06-24340
K871538STAT-PAD (TM)Cardiac Resucitator Corp.1987-06-24650
K871569MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATORCardiac Resucitator Corp.1987-06-08450
K870622HEART*AID 1000Cardiac Resucitator Corp.1987-04-10570
K850596PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &Cardiac Resucitator Corp.1985-03-06190
K850170HEART AID MODEL 97Cardiac Resucitator Corp.1985-02-14290
K844811PACE AID MODEL 53Cardiac Resucitator Corp.1985-01-24440
K843547PACE *AID MODEL 52Cardiac Resucitator Corp.1984-12-17980
K843358HEART-AID MODEL 80Cardiac Resucitator Corp.1984-11-19840
K841556HEART - AID ALS, 95Cardiac Resucitator Corp.1984-07-19940
K821673HEART*AID, ALS, MODEL 95Cardiac Resucitator Corp.1982-08-06600
K821152HEART AID #90Cardiac Resucitator Corp.1982-08-061020
K820609HEART *AID, #80Cardiac Resucitator Corp.1982-08-061510
K820507PACE* AID MODEL 50Cardiac Resucitator Corp.1982-08-061620
K813553PACE *AIDCardiac Resucitator Corp.1982-01-18270
K811028PACE AIDCardiac Resucitator Corp.1981-04-1600

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