Marine Polymer Technologies, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Marine Polymer Technologies, Inc.” (first 1997, latest 2016), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 104 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 | 1 | 373 |
| 2015 | 0 | — |
| 2016 | 1 | 267 |
| 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 3 | 3 |
| DXC | Clamp, Vascular | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| MTJ | Wax, Bone | 1 | 1 |
Review panels
Most recent Marine Polymer Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160695 | Talymed Suspension | FRO | 2016-12-06 | 267 |
| K132293 | SYVEK RADIAL BAND | DXC | 2014-07-31 | 373 |
| K111524 | MP 719 | MTJ | 2011-07-22 | 50 |
| K102002 | TALYMED | FRO | 2010-07-28 | 13 |
| K082703 | MRDH BANDAGE | KMF | 2008-10-14 | 28 |
| K070557 | MP 719 | FRO | 2007-05-23 | 85 |
| K053300 | SYVEKEXCEL | DXC | 2006-03-28 | 123 |
| K002550 | RDH BANDAGE | KMF | 2000-12-20 | 125 |
| K984177 | MODIFICATION TO SKVEKPATCH | KMF | 1998-12-18 | 28 |
| K972914 | SYVEK PATCH | KGX | 1997-12-22 | 137 |
Recalls
openFDA lists no recalls under a recalling firm named Marine Polymer Technologies, Inc..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Marine Polymer Technologies, Inc. (8)
- Marine Polymer Technologies (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Marine Polymer Technologies, Inc.?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Marine Polymer Technologies, Inc.” (first 1997, latest 2016), across 5 product codes in 3 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 Marine Polymer Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marine Polymer Technologies, Inc. is 104 days.
Which FDA product codes appear under Marine Polymer Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 3); DXC (Clamp, Vascular, 2).
Next steps
- See all 10 Marine Polymer Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Marine Polymer Technologies, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.