Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medi-Craft , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
155 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861949 | SUCTION CATHETER KIT | Medi-Craft , Ltd. | 1986-10-22 | 155 | 0 |
| K800508 | STOMACH TUBES | Medi-Craft , Ltd. | 1980-04-08 | 35 | 0 |
| K800507 | FEEDING TUBES | Medi-Craft , Ltd. | 1980-04-08 | 35 | 0 |
| K800510 | RECTAL & HARRIS FLUSH TUBES | Medi-Craft , Ltd. | 1980-04-08 | 35 | 0 |
| K800505 | URETHRAL CATHETER | Medi-Craft , Ltd. | 1980-04-08 | 35 | 0 |
| K800506 | OXYGEN CATHETER | Medi-Craft , Ltd. | 1980-03-25 | 21 | 0 |
| K800509 | CONNECTING TUBES | Medi-Craft , Ltd. | 1980-03-25 | 21 | 0 |
| K800503 | SUCTION CATHETER | Medi-Craft , Ltd. | 1980-03-18 | 14 | 0 |
| K800504 | OXYGEN CONNECTING TUBES | Medi-Craft , Ltd. | 1980-03-18 | 14 | 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