Devon Medical Products: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Devon Medical Products” (first 2012, latest 2016), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 96 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 | 1 | 395 |
| 2013 | 0 | — |
| 2014 | 1 | 120 |
| 2015 | 3 | 71 |
| 2016 | 1 | 33 |
| 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 3 | 3 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| HGX | Pump, Breast, Powered | 1 | 1 |
Review panels
Most recent Devon Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161209 | Cirona 6400 | JOW | 2016-05-31 | 33 |
| K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System | JOW | 2015-09-18 | 137 |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc | OMP | 2015-06-09 | 29 |
| K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister | OMP | 2015-02-03 | 71 |
| K142168 | NATURE'S BOND 600 AND NATURE'S BOND 603 | HGX | 2014-12-04 | 120 |
| K110078 | EXTRICARE | OMP | 2012-02-10 | 395 |
Recalls
openFDA lists no recalls under a recalling firm named Devon Medical Products.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Devon Industries, Inc. (47 510(k)s)
- Devon Medical, Inc. (13 510(k)s)
- Devon Medical Products (Jiangsu), Ltd. (6 510(k)s)
- Devon Safety Products, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Devon Medical Products?
FDA lists 6 510(k) clearances under the applicant name “Devon Medical Products” (first 2012, latest 2016), across 3 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 Devon Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devon Medical Products is 96 days.
Which FDA product codes appear under Devon Medical Products?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 3); JOW (Sleeve, Limb, Compressible, 2); HGX (Pump, Breast, Powered, 1).
Next steps
- See all 6 Devon Medical Products clearances with predicates and recalls
- Run predicate analysis for product code OMP, Devon Medical Products'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.