Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hysterx, Inc. · 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) |
|---|---|---|---|---|---|
| K000911 | MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 | Hysterx, Inc. | 2000-04-14 | 24 | 0 |
| K993695 | LIGA-LOOP SUTURE APPLICATOR | Hysterx, Inc. | 2000-04-13 | 163 | 0 |
| K992714 | MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 | Hysterx, Inc. | 1999-10-05 | 54 | 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