Devon Medical Products (Jiangsu), Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Devon Medical Products (Jiangsu), Ltd.” (first 2017, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 124 days. Since 2017 the median was 124 days, against 134 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 2 | 130 |
| 2018 | 2 | 108 |
| 2019 | 2 | 90 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Devon Medical Products (Jiangsu), Ltd. took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Devon Medical Products (Jiangsu), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System | JOW | 2019-03-19 | 25 |
| K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device | JOW | 2019-02-21 | 155 |
| K182150 | Devon 52 Sequential Compression Device | JOW | 2018-12-18 | 132 |
| K173528 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System | JOW | 2018-02-06 | 83 |
| K172030 | Devon 51 | JOW | 2017-11-27 | 145 |
| K170814 | Devon 24 | JOW | 2017-07-11 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Devon Medical Products (Jiangsu), 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.
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 (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 (Jiangsu), Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Devon Medical Products (Jiangsu), Ltd.” (first 2017, latest 2019), across 1 product code in 1 review panel. 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 (Jiangsu), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Devon Medical Products (Jiangsu), Ltd. is 124 days. Since 2017: 124 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Devon Medical Products (Jiangsu), Ltd.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 6).
Next steps
- See all 6 Devon Medical Products (Jiangsu), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Devon Medical Products (Jiangsu), 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.