Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HMG — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900161 | A-SCAN ROLL-AROUND STAND | Jedmed Instrument Co. | 1990-02-16 | 35 | 0 |
| K883575 | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-09-12 | 21 | 0 |
| K873554 | GORSK INSTRUMENT REST | Gorsk, Inc. | 1987-10-23 | 56 | 0 |
| K841759 | OPHTHALMIC TABLE | Woodlyn, Inc. | 1984-06-01 | 35 | 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