Devon Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Devon Medical, Inc.” (first 2009, latest 2014), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 | 6 | 70 |
| 2014 | 3 | 191 |
| 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 8 | 8 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 4 | 4 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
Most recent Devon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit | OMP | 2014-09-19 | 191 |
| K141578 | DEVON CIRONA 6200 DVT | JOW | 2014-06-27 | 14 |
| K132225 | EXTRICARE | OMP | 2014-05-15 | 302 |
| K132252 | EXTRICARE 100CC/ 250CC/ 400CC CANISTERS | OMP | 2013-09-27 | 70 |
| K131464 | EXTRICARE NPWT FOOT DRESSING | OMP | 2013-08-13 | 84 |
| K131743 | CIRONA DVT FOOT GARMENT | JOW | 2013-07-01 | 18 |
| K130571 | DEVON CIRONA 6100 DVT | JOW | 2013-04-09 | 36 |
| K123959 | CIRCUFLOW 5150 | JOW | 2013-02-28 | 69 |
| K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | JOW | 2013-02-14 | 79 |
| K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | JOW | 2010-10-07 | 29 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Devon Medical, 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.
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 Products (6 510(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, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Devon Medical, Inc.” (first 2009, latest 2014), across 3 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 Devon Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devon Medical, Inc. is 36 days.
Which FDA product codes appear under Devon Medical, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 8); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 4); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 13 Devon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Devon Medical, 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, 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.