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Xltek
Model 017866 · XLTEK · DI 00382830046169
GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.79
2019-02
0
4.2
2019-03
0
3.5
2019-04
0
2
2019-05
0
1.74
2019-06
0
1.59
2019-07
0
2.05
2019-08
0
4.71
2019-09
0
2.84
2019-10
0
5.53
2019-11
0
5.35
2019-12
0
5.35
2020-01
0
4.61
2020-02
0
2.44
2020-03
0
4.64
2020-04
0
2.73
2020-05
0
1.67
2020-06
0
1.75
2020-07
0
3.19
2020-08
0
3.21
2020-09
0
3.17
2020-10
0
4.64
2020-11
0
2.76
2020-12
0
3.42
2021-01
0
1.18
2021-02
0
2.64
2021-03
0
2.13
2021-04
0
2.19
2021-05
0
1.88
2021-06
0
2.52
2021-07
0
3.61
2021-08
0
2.33
2021-09
0
4.67
2021-10
0
2.82
2021-11
0
2.27
2021-12
0
1.71
2022-01
0
2.54
2022-02
0
2.47
2022-03
0
1.67
2022-04
0
2.6
2022-05
0
2.75
2022-06
0
2.27
2022-07
0
1.93
2022-08
0
2.12
2022-09
0
2.08
2022-10
0
2.76
2022-11
0
2.5
2022-12
0
2.21
2023-01
0
3
2023-02
0
2.19
2023-03
0
2
2023-04
0
1.45
2023-05
0
2.42
2023-06
0
1.63
2023-07
0
1.78
2023-08
0
3.06
2023-09
0
3.85
2023-10
0
6.85
2023-11
0
6.79
2023-12
0
8
2024-01
0
4.86
2024-02
0
5.86
2024-03
0
7.86
2024-04
0
11.14
2024-05
0
10.11
2024-06
0
7.79
2024-07
0
11.61
2024-08
0
12.61
2024-09
0
20.53
2024-10
0
15.26
2024-11
0
14.03
2024-12
0
9.43
2025-01
0
8.92
2025-02
0
12.45
2025-03
0
17.41
2025-04
0
10.93
2025-05
0
8.77
2025-06
0
10.62
2025-07
0
16.03
2025-08
0
10.15
2025-09
0
11.17
2025-10
0
15.45
2025-11
0
13.97
2025-12
0
12.62
2026-01
0
9.92
2026-02
0
10.95
2026-03
0
12.51
2026-04
0
13.09
2026-05
0
15.6
2026-06
0
14.45
This device (reports/month)Average device in GWF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K093304 — cited as predicate by K132616, K162199, K190703
Lineage extracted from public 510(k) summary text (heuristic).