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1077 Accessory Box AB07
Model 8-69-41350 · PATH medical GmbH · DI 04260223146022
GWJ — Stimulator, Auditory, Evoked Response · Class II · 21 CFR 882.1900
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2025-11-06
Z-0940-2026
Class II
Open, Classified
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
k number procode
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
1.4
2019-02
0
3
2019-03
0
2
2019-04
0
1.31
2019-05
0
1.88
2019-06
0
1.5
2019-07
0
3.67
2019-08
0
1.33
2019-09
0
1.67
2019-10
0
3.5
2019-11
0
5.17
2019-12
0
3.67
2020-01
0
3.67
2020-03
0
3.13
2020-04
0
2.2
2020-05
0
1.25
2020-06
0
1.43
2020-07
0
4.17
2020-08
0
2.5
2020-09
0
1.83
2020-10
0
2
2020-11
0
2
2020-12
0
3.43
2021-01
0
1.5
2021-03
0
4.33
2021-04
0
1.78
2021-05
0
2.67
2021-06
0
1.67
2021-07
0
3.88
2021-08
0
2
2021-09
0
2
2021-10
0
1.29
2021-11
0
2.33
2021-12
0
1.6
2022-01
0
1.5
2022-02
0
4
2022-03
0
1.67
2022-04
0
3.5
2022-06
0
1
2022-08
0
1.33
2022-10
0
1.33
2022-12
0
2
2023-01
0
2
2023-02
0
1.25
2023-03
0
2
2023-04
0
2
2023-05
0
1.33
2023-06
0
1.43
2023-07
0
1.5
2023-08
0
4
2023-09
0
2
2023-10
0
2
2023-11
0
1.6
2023-12
0
2.75
2024-01
0
1.38
2024-02
0
2.33
2024-03
0
2.5
2024-04
0
1.33
2024-05
0
1.67
2024-06
0
3.5
2024-07
0
4.29
2024-08
0
3.36
2024-09
0
6.86
2024-10
0
4.43
2024-11
0
4.33
2024-12
0
3.5
2025-01
0
2.88
2025-02
0
5.11
2025-03
0
13.25
2025-04
0
2
2025-05
0
3.11
2025-06
0
2.29
2025-07
0
5.13
2025-08
0
3.89
2025-09
0
1.78
2025-10
0
5.25
2025-11
0
3.38
2025-12
0
3.4
2026-01
0
3
2026-02
0
1.2
2026-03
0
3.75
2026-04
0
2.13
2026-05
0
3
2026-06
0
2.13
This device (reports/month)Average device in GWJ (reports/device/month)
Regulatory clearances
K100661 SESE 2010-07-01 (k number procode)
Predicate lineage
K100661 — cited as predicate by K133012
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — PATH medical GmbH