Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K134055Substantially equivalent (SESE) · 2014-05-09clearance family
Predicate lineage
K134055
Cited as predicate by: K190935
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-02-23 | VAI | Voluntary action indicated | Dexcowin Co. Ltd. | 1 |
| 2023-02-23 | VAI | Voluntary action indicated | Dexcowin Co. Ltd. | 1 |
| 2019-06-06 | NAI | No action indicated | Dexcowin Co. Ltd. | 0 |
| 2019-06-06 | NAI | No action indicated | Dexcowin Co. Ltd. | 0 |
| 2018-02-20 | WL | Warning Letter | Dexcowin Co. Ltd. | — |
| 2018-02-20 | WL | Warning Letter | Dexcowin Co. Ltd. | — |
| 2017-08-31 | OAI | Official action indicated | Dexcowin Co. Ltd. | 16 |
| 2017-08-31 | OAI | Official action indicated | Dexcowin Co. Ltd. | 16 |
| 2015-08-15 | WL | Warning Letter | Dexcowin Co. Ltd. | — |
| 2015-08-15 | WL | Warning Letter | Dexcowin Co. Ltd. | — |
| 2015-03-26 | OAI | Official action indicated | Dexcowin Co. Ltd. | 8 |
| 2015-03-26 | OAI | Official action indicated | Dexcowin Co. Ltd. | 8 |
| 2011-06-03 | VAI | Voluntary action indicated | Dexcowin Co. Ltd. | 0 |
| 2011-06-03 | VAI | Voluntary action indicated | Dexcowin Co. Ltd. | 0 |
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