Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devon Medical Products (Jiangsu), Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
155 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190423 | Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy Syst | Devon Medical Products (Jiangsu), Ltd. | 2019-03-19 | 25 | 0 |
| K182578 | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Devic | Devon Medical Products (Jiangsu), Ltd. | 2019-02-21 | 155 | 0 |
| K182150 | Devon 52 Sequential Compression Device | Devon Medical Products (Jiangsu), Ltd. | 2018-12-18 | 132 | 0 |
| K173528 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy Syst | Devon Medical Products (Jiangsu), Ltd. | 2018-02-06 | 83 | 0 |
| K172030 | Devon 51 | Devon Medical Products (Jiangsu), Ltd. | 2017-11-27 | 145 | 0 |
| K170814 | Devon 24 | Devon Medical Products (Jiangsu), Ltd. | 2017-07-11 | 116 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda