Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hedeco — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830497 | PEM-T | Hedeco | 1983-04-05 | 48 | 0 |
| K822380 | ROMBEAU GASTROSTOMY-JEJUNAL TUBE | Hedeco | 1982-09-17 | 39 | 0 |
| K820063 | KEOFEED 500 ENTERIC FEEDING PUMP | Hedeco | 1982-02-10 | 30 | 0 |
| K812507 | THE KEOFEED STOMACH TUBE | Hedeco | 1981-09-14 | 13 | 0 |
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