Atlas FDA

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

Megaplast, Inc. — Predicate Candidate Screening

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

48 daysmedian FDA review time
82 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K822158OPEN HEART TRAY (CUSTOM DESIGNED)Megaplast, Inc.1982-10-13820
K821313SURGICAL UTILITY DRAPEMegaplast, Inc.1982-06-21480
K820423SUTURE REMOVAL TRAYMegaplast, Inc.1982-03-10220
K820136URINARY DRAINAGE BAGMegaplast, Inc.1982-01-29110
K810249TRAY, CATHERIZATION, URETHRALMegaplast, Inc.1981-04-07680
K810250TRAY, IRRIGATIONMegaplast, Inc.1981-04-07680
K810251SYRINGE, ENTMegaplast, Inc.1981-03-11410

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