Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mednet Locator, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
124 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REP | Mednet Locator, Inc. | 2000-08-08 | 97 | 0 |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLAC | Mednet Locator, Inc. | 2000-08-08 | 97 | 0 |
| K974174 | ULTRABUR | Mednet Locator, Inc. | 1998-03-10 | 124 | 0 |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Mednet Locator, Inc. | 1997-09-05 | 45 | 0 |
| K972734 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) | Mednet Locator, Inc. | 1997-09-05 | 45 | 0 |
| K972737 | CAUSSE PISTON | Mednet Locator, Inc. | 1997-09-05 | 45 | 0 |
| K972126 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-29 | 54 | 0 |
| K972400 | MYRINGOTOMY TUBE - BOBBIN WITH TAB | Mednet Locator, Inc. | 1997-07-23 | 48 | 0 |
| K971943 | MYRINGOTOMY TUBE | Mednet Locator, Inc. | 1997-07-23 | 57 | 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