Atlas FDA

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

Micromedical, Inc. — Predicate Candidate Screening

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

284 daysmedian FDA review time
293 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974352CARDIOVIEW 3000 SOFTWAREMicromedical, Inc.1998-09-082930
K974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEMicromedical, Inc.1998-08-252860
K974351BIOLOG 3000 ELECTROCARDIOGRAPHMicromedical, Inc.1998-04-011330
K970305PRINTER INTERFACEMicromedical, Inc.1997-08-152000
K955891CARDIOVIEW TRANSTELEPHONIC SOFTWAREMicromedical, Inc.1996-10-082840

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