Mpm Medical., Inc.: FDA clearances and approvals
Mpm Medical., Inc. has 9 FDA 510(k) clearances (first 1993, latest 2006), across 4 product codes in 2 review panels. Median 510(k) review time: 89 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 5 | 5 |
| OLR | Oral Wound Dressing | 2 | 2 |
| KMF | Bandage, Liquid | 1 | 1 |
| SEJ | Wound Dressings Containing Topical Analgesics | 1 | 1 |
Review panels
Most recent Mpm Medical., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | OLR | 2006-05-10 | 89 |
| K024180 | ORAMAGICRX ORAL WOUND RINSE | OLR | 2003-03-14 | 86 |
| K020540 | REGENECARE WOUND GEL | SEJ | 2002-11-01 | 255 |
| K992074 | MPM REGENECARE WOUND GEL | MGQ | 1999-12-23 | 188 |
| K962160 | MPM HYDROGEL DRESSING (NON-STERILE) | MGQ | 1996-06-26 | 22 |
| K952276 | MPM HYDROGEL DRESSING | MGQ | 1995-06-30 | 46 |
| K942798 | MPM HYDROGEL | MGQ | 1994-07-11 | 26 |
| K930560 | MPM HYDROGEL SATURATED DRESSING | MGQ | 1993-07-08 | 155 |
| K926044 | MPM WET DRESSING (SALINE) | KMF | 1993-04-08 | 128 |
Recalls
openFDA lists no recalls under a recalling firm named Mpm Medical., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Mpm Medical., Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04407364: MPM Medical CoMatryx Surgical Bovine Collagen Study (Active not recruiting, started 2020-09-02)
Frequently asked questions
How many FDA 510(k) clearances does Mpm Medical., Inc. have?
Mpm Medical., Inc. has 9 FDA 510(k) clearances (first 1993, latest 2006), across 4 product codes in 2 review panels.
How long does FDA take to clear Mpm Medical., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mpm Medical., Inc.'s cleared 510(k)s is 89 days.
What devices does Mpm Medical., Inc. make?
Its most frequent FDA product codes are MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 5); OLR (Oral Wound Dressing, 2); KMF (Bandage, Liquid, 1).
Has Mpm Medical., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mpm Medical., Inc. Related entities may recall under other names.
Next steps
- See all 9 Mpm Medical., Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGQ, Mpm Medical., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.