Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtrex, 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) |
|---|---|---|---|---|---|
| K981724 | O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 | Medtrex, Inc. | 1998-06-22 | 38 | 0 |
| K970130 | HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPE | Medtrex, Inc. | 1997-03-28 | 72 | 0 |
| K970039 | ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) | Medtrex, Inc. | 1997-02-26 | 51 | 0 |
| K952577 | ELECTROSURGICAL DISPERSIVE ELECTRODE | Medtrex, Inc. | 1995-06-14 | 9 | 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