Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hg Innovations, Ltd. — 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) |
|---|---|---|---|---|---|
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm | Hg Innovations, Ltd. | 2023-11-20 | 52 | 0 |
| K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm | Hg Innovations, Ltd. | 2023-11-20 | 52 | 0 |
| K230432 | Single Use Bipolar Forceps | Hg Innovations, Ltd. | 2023-05-18 | 90 | 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