Atlas FDA

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

Instruments For Cardiac Research — Predicate Candidate Screening

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

44 daysmedian FDA review time
212 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K834397HOLTER CARDIOGRAPHY SYS 6201Instruments For Cardiac Research1984-04-171250
K821173EVENTMASTER 3 HOLTER EVENT SCANNERInstruments For Cardiac Research1982-05-18220
K820856EVENTMASTER 2Instruments For Cardiac Research1982-04-29310
K820011CARDIOSTRESSInstruments For Cardiac Research1982-01-22170
K812920EVENT MASTERInstruments For Cardiac Research1981-12-02440
K801903SERIES 4000 STRESS & EXERCISE SYSTEMInstruments For Cardiac Research1981-03-112120
K771374SCANNER TREND SYSTEMInstruments For Cardiac Research1977-08-04100
K770705CARDIAC ACQUISITION SYSTEM, ICR 2001Instruments For Cardiac Research1977-06-02450

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