Atlas FDA

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

Mega Medical, Inc. — Predicate Candidate Screening

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

93 daysmedian FDA review time
137 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.1992-03-30900
K913397MEGA ANGIOGRAM KITMega Medical, Inc.1991-10-31930
K913317MEGA ARTHROGRAM KITMega Medical, Inc.1991-10-31980
K912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KITMega Medical, Inc.1991-10-181370
K913382MEGA PARACENTESIS KITMega Medical, Inc.1991-10-08710
K912322MEGA SPINAL ANESTHESIA KITMega Medical, Inc.1991-09-261250
K912564MEGA PERICARDIOCENTESIS KITMega Medical, Inc.1991-09-05860

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