Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mpathy Medical Devices, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
154 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | Mpathy Medical Devices, Ltd. | 2009-08-12 | 21 | 0 |
| K091180 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2009-07-14 | 82 | 0 |
| K073647 | MINITAPE EXTRA URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-03-03 | 68 | 0 |
| K073646 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-02-25 | 61 | 0 |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2006-02-06 | 66 | 1 |
| K041632 | MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2004-11-17 | 154 | 1 |
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