Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Action Industries, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
220 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042526 | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, | Medical Action Industries, Inc. | 2005-04-25 | 220 | 0 |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | 2004-11-08 | 52 | 0 |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Medical Action Industries, Inc. | 2002-11-04 | 60 | 0 |
| K946019 | SURGICLA INSTRUMENT KIT | Medical Action Industries, Inc. | 1995-03-20 | 98 | 0 |
| K923846 | BURN DRESSING | Medical Action Industries, Inc. | 1992-09-11 | 42 | 0 |
| K884826 | GAUZE SPONGE | Medical Action Industries, Inc. | 1988-12-22 | 34 | 0 |
| K810685 | SUTURE REMOVAL KIT | Medical Action Industries, Inc. | 1981-03-26 | 13 | 0 |
| K810184 | LAPAROTOMY SPONGE | Medical Action Industries, Inc. | 1981-02-04 | 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