Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Specialty Medical Products Co. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924707 | VARIOUS ANESTHETIC KITS OR TRAYS | Specialty Medical Products Co. | 1993-06-17 | 272 | 0 |
| K922533 | IV START KIT CUSTOM SMP # A-Z | Specialty Medical Products Co. | 1993-03-23 | 299 | 0 |
| K922845 | BASIC DRESSING CHANGE TRAY SMP 102A | Specialty Medical Products Co. | 1992-12-29 | 200 | 0 |
| K874596 | PERFORATED SOAKING TUBE | Specialty Medical Products Co. | 1987-12-02 | 23 | 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