Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Howard Medical Co. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962234 | STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16P | Howard Medical Co. | 1996-06-28 | 17 | 0 |
| K882115 | A-SORB | Howard Medical Co. | 1988-10-03 | 137 | 0 |
| K820195 | OR SPECIALTIES VAGINAL PACK | Howard Medical Co. | 1982-03-05 | 39 | 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