Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dexcowin Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
300 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173046 | Cocoon Portable Handheld X-Ray System | Dexcowin Co., Ltd. | 2017-10-26 | 28 | 0 |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | 2015-10-05 | 300 | 0 |
| K134055 | ADX4000W | Dexcowin Co., Ltd. | 2014-05-09 | 129 | 0 |
| K133007 | DX3000-L | Dexcowin Co., Ltd. | 2014-04-24 | 211 | 0 |
| K083532 | ADX4000-L, DX3000-L | Dexcowin Co., Ltd. | 2009-03-10 | 102 | 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