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
Predicate lineage
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 |
|---|---|---|---|---|
| 2018-07-19 | NAI | No action indicated | Vilex in Tennessee, Inc. | 0 |
| 2018-01-10 | WL | Warning Letter | Vilex in Tennessee, Inc. | — |
| 2017-08-25 | OAI | Official action indicated | Vilex in Tennessee, Inc. | 5 |
| 2012-11-01 | VAI | Voluntary action indicated | Vilex in Tennessee, Inc. | 7 |
| 2010-09-01 | VAI | Voluntary action indicated | Vilex in Tennessee, Inc. | 4 |
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