Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Marwood Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
114 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850340 | EYE PROCEDURE PACK | Marwood Medical, Inc. | 1985-05-22 | 114 | 0 |
| K850338 | EMERGENCY ROOM PACK | Marwood Medical, Inc. | 1985-03-25 | 56 | 0 |
| K850339 | SPECIAL PROCEDURES PACK | Marwood Medical, Inc. | 1985-03-12 | 43 | 0 |
| K850337 | CARDIAC CATHETERIZATION PACK | Marwood Medical, Inc. | 1985-02-25 | 28 | 0 |
| K850341 | CARDIOVASCULAR SET UP | Marwood Medical, Inc. | 1985-02-25 | 28 | 0 |
| K840620 | TPN/CVP DRESSING CHANGE KIT | Marwood Medical, Inc. | 1984-05-30 | 106 | 0 |
| K840619 | I.V. START KIT | Marwood Medical, Inc. | 1984-03-27 | 42 | 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