Atlas FDA

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

Health Development Corp. — Predicate Candidate Screening

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

57 daysmedian FDA review time
139 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830397PEM-CHealth Development Corp.1983-04-12640
K823937SEMINAL COLLECTION DEVICEHealth Development Corp.1983-02-24570
K810499PERCUTANEOUS GASTROINTESTINAL TUBEHealth Development Corp.1981-03-0480
K802482KEOFEED (R) EASY-FILL ENTERIC FEED BAGHealth Development Corp.1980-10-31240
K791714SURGIFEEDHealth Development Corp.1980-01-161390

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