Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
National Catheter Co. Div. Mallinckrodt · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
153 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802918 | ANTHRON CATHETER SET | National Catheter Co. Div. Mallinckrodt | 1981-04-21 | 153 | 0 |
| K802505 | DOUBLE LUMEN TRACHEAL TUBE | National Catheter Co. Div. Mallinckrodt | 1981-03-13 | 149 | 0 |
| K810321 | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) | National Catheter Co. Div. Mallinckrodt | 1981-03-04 | 26 | 0 |
| K801924 | HI-LO TEMP GEN. PURPOSE TEMP. PROBE | National Catheter Co. Div. Mallinckrodt | 1980-09-09 | 28 | 0 |
| K801005 | MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) | National Catheter Co. Div. Mallinckrodt | 1980-05-23 | 25 | 0 |
| K791190 | STETHOSCOPE WITH TEMPERATURE SENSOR | National Catheter Co. Div. Mallinckrodt | 1979-07-06 | 10 | 0 |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | 1978-12-15 | 78 | 0 |
| K770727 | MANIPULATOR & INJECTOR, UTERINE | National Catheter Co. Div. Mallinckrodt | 1977-04-26 | 7 | 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