Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
M.D. Engineering, Inc. — 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) |
|---|---|---|---|---|---|
| K912882 | INNERVISION LAPAROSCOPE AND ACCESSORIES | M.D. Engineering, Inc. | 1992-01-24 | 207 | 0 |
| K910983 | IV 1000 INSUFFLATOR RAPID FLOW | M.D. Engineering, Inc. | 1991-12-09 | 277 | 0 |
| K910982 | INNERVISION IRRIGATION PUMP | M.D. Engineering, Inc. | 1991-08-26 | 172 | 0 |
| K883384 | TS1000 SUCTION TIP | M.D. Engineering, Inc. | 1988-11-02 | 85 | 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