Mpathy Medical Devices, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mpathy Medical Devices, Ltd.” (first 2004, latest 2009), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 66 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 2 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 2 | 2 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 2 | 2 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 | 1 |
Review panels
Most recent Mpathy Medical Devices, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | OTN | 2009-08-12 | 21 |
| K092207 | RESTORELLE POLYPROPYLENE MESH | OTP | 2009-08-04 | 13 |
| K091180 | MINITAPE URETHRAL SLING | PAH | 2009-07-14 | 82 |
| K073647 | MINITAPE EXTRA URETHRAL SLING | OTN | 2008-03-03 | 68 |
| K073646 | MINITAPE URETHRAL SLING | PAH | 2008-02-25 | 61 |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | OTO | 2006-02-06 | 66 |
| K041632 | MINIMESH POLYPROPYLENE MESH | OTO | 2004-11-17 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Mpathy Medical Devices, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mpathy Medical Devices, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Mpathy Medical Devices, Ltd.” (first 2004, latest 2009), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mpathy Medical Devices, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mpathy Medical Devices, Ltd. is 66 days.
Which FDA product codes appear under Mpathy Medical Devices, Ltd.?
The most frequent FDA product codes under this applicant name are OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 2); OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, 2); PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling, 2).
Next steps
- See all 7 Mpathy Medical Devices, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OTN, Mpathy Medical Devices, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.