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

Bio Mega Diagnostic, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
68 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864659BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSHBio Mega Diagnostic, Inc.1987-02-04680
K822438BIOMEGA MODEL 59WBio Mega Diagnostic, Inc.1982-09-21390
K813556MOD. 587 BLOOD PRESSURE & PULSE MONITORBio Mega Diagnostic, Inc.1982-01-22310
K801923BIOMEGA #423-B BLOOD PRESSURE & PULSE CKBio Mega Diagnostic, Inc.1980-08-27150
K760930BLOOD PRESSURE & PULSE CHECKERBio Mega Diagnostic, Inc.1976-11-09110

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