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Model 190289-200 · CADWELL INDUSTRIES, INC. · DI 00840067100073
GWE — Stimulator, Photic, Evoked Response · Class II · 21 CFR 882.1890
GWL — Amplifier, Physiological Signal · Class II · 21 CFR 882.1835
GWQ — Full-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
OLT — Non-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400
OLV — Standard Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400
OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400
UDILibrary device dossier · generated 2026-09-12 · 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
1.58
2019-02
0
3
2019-03
0
2
2019-04
0
1.33
2019-05
0
1.88
2019-06
0
1.57
2019-07
0
3.29
2019-08
0
1.33
2019-09
0
1.62
2019-10
0
3.35
2019-11
0
5.17
2019-12
0
3.67
2020-01
0
3.46
2020-02
0
1
2020-03
0
3.13
2020-04
0
2.09
2020-05
0
1.25
2020-06
0
1.5
2020-07
0
4.17
2020-08
0
2.5
2020-09
0
1.83
2020-10
0
2
2020-11
0
2.09
2020-12
0
3.43
2021-01
0
1.4
2021-03
0
4.13
2021-04
0
1.78
2021-05
0
2.67
2021-06
0
1.67
2021-07
0
4
2021-08
0
2
2021-09
0
2
2021-10
0
1.27
2021-11
0
2.33
2021-12
0
1.64
2022-01
0
1.5
2022-02
0
3.33
2022-03
0
1.5
2022-04
0
3.22
2022-05
0
1
2022-06
0
1
2022-08
0
1.33
2022-10
0
1.5
2022-11
0
1
2022-12
0
1.88
2023-01
0
2.33
2023-02
0
1.33
2023-03
0
2
2023-04
0
2
2023-05
0
2.83
2023-06
0
1.33
2023-07
0
1.55
2023-08
0
5.33
2023-09
0
2
2023-10
0
2.4
2023-11
0
2.27
2023-12
0
2.94
2024-01
0
1.47
2024-02
0
2.25
2024-03
0
2.3
2024-04
0
1.38
2024-05
0
1.75
2024-06
0
3.33
2024-07
0
4.67
2024-08
0
3.36
2024-09
0
5.56
2024-10
0
4.43
2024-11
0
4.05
2024-12
0
3.32
2025-01
0
2.43
2025-02
0
4.95
2025-03
0
12
2025-04
0
1.95
2025-05
0
3.11
2025-06
0
2
2025-07
0
4.88
2025-08
0
3.79
2025-09
0
2
2025-10
0
4.45
2025-11
0
3.05
2025-12
0
3.08
2026-01
0
3
2026-02
0
2.08
2026-03
0
3.35
2026-04
0
2.65
2026-05
0
2.22
2026-06
0
2.21
This device (reports/month)Average device in GWE, GWL, GWQ, OLT, OLV, OMC (reports/device/month)
Regulatory clearances
K133355 SESE 2014-01-29 (k number procode)
Predicate lineage
K133355 — cites (transitively): K091728 (d1), K093728 (d1), K971214 (d1), K052066 (d2), K061996 (d2) — cited as predicate by K180269
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CADWELL INDUSTRIES, INC.
VAI 2017-08-16 Cadwell Industries Inc · 3 citations
VAI 2017-08-16 Cadwell Industries Inc · 3 citations
VAI 2013-04-30 Cadwell Industries Inc · 3 citations
VAI 2013-04-30 Cadwell Industries Inc · 3 citations