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
- K230064
- K050438
- K131425
- K150231
- K160713
- K163581
- K172199
- K182104
- K182121
- K183644
- K201267
- K202552
- K203005
- K211441
- K211596
- K212005
- K214011
- K222383
- K251316
- K050438
- K131425
- K150231
- K160713
- K163581
- K172199
- K182104
- K182121
- K183644
- K201267
- K202552
- K211441
- K211596
- K212005
- K212524
- K214011
- K222383
- K230064
- K231184
- K232141
- K233951
- K241605
Cited as predicate by: K253381
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
None in the loaded window.
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