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)K242813Substantially equivalent (SESE) · 2024-10-18clearance family
- 510(k)K241143Substantially equivalent (SESE) · 2024-05-22clearance family
- 510(k)K233408Substantially equivalent (SESE) · 2023-11-09clearance family
Predicate lineage
- K233408
- K051075
- K052472
- K062250
- K080402
- K092122
- K092873
- K100448
- K100858
- K110598
- K111629
- K112438
- K113254
- K120174
- K130050
- K130642
- K131559
- K133349
- K142139
- K142413
- K143256
- K152047
- K153602
- K161189
- K162024
- K170893
- K172054
- K173717
- K181999
- K183039
- K183077
- K190286
- K193560
- K202716
- K203694
- K212569
- K212737
- K213387
- K220452
- K220792
- K220847
- K230572
- K231112
- K241143
- K051075
- K052472
- K062250
- K080402
- K092122
- K092873
- K100448
- K100858
- K110598
- K111629
- K112438
- K113254
- K120174
- K130050
- K130642
- K131559
- K133349
- K142139
- K142413
- K143256
- K152047
- K153602
- K161189
- K162024
- K170893
- K172054
- K173717
- K181999
- K183077
- K190286
- K193560
- K202716
- K203694
- K212569
- K212737
- K212933
- K213387
- K220452
- K220792
- K220847
- K221467
- K222427
- K230315
- K230572
- K231112
- K233408
- K242813
- K051075
- K052472
- K062250
- K080402
- K092122
- K092873
- K100448
- K100858
- K110598
- K111629
- K112438
- K113254
- K120174
- K130050
- K130642
- K131559
- K133349
- K142139
- K142413
- K143256
- K152047
- K153602
- K161189
- K162024
- K170893
- K172054
- K173717
- K181999
- K183077
- K190286
- K193560
- K202716
- K203694
- K212569
- K212737
- K212933
- K213387
- K220452
- K220792
- K220847
- K221467
- K222427
- K222592
- K230315
- K230572
- K230831
- K231112
- K233408
- K233481
- K241143
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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