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PlethRing sensor Small (17mm)
Model ABP510/S · SOMNOmedics AG · DI 04250413405886
DSH — Recorder, Magnetic Tape, Medical · Class II · 21 CFR 870.2800
DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130
UDILibrary device dossier · generated 2026-09-11 · 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
6
2019-02
0
1.89
2019-03
0
10
2019-04
0
4.67
2019-05
0
4.75
2019-06
0
7.6
2019-07
0
4.14
2019-08
0
3.89
2019-09
0
5
2019-10
0
5.25
2019-11
0
3.2
2019-12
0
3.25
2020-01
0
11.33
2020-02
0
4.1
2020-03
0
5.5
2020-04
0
4.25
2020-05
0
2.25
2020-06
0
5.4
2020-07
0
3.75
2020-08
0
5.83
2020-09
0
6.75
2020-10
0
5.33
2020-11
0
9.6
2020-12
0
7.43
2021-01
0
4.67
2021-02
0
3.75
2021-03
0
4.57
2021-04
0
5.4
2021-05
0
7.8
2021-06
0
6.71
2021-07
0
5.38
2021-08
0
7.56
2021-09
0
4.38
2021-10
0
2.36
2021-11
0
2.67
2021-12
0
4.67
2022-01
0
3.22
2022-02
0
4.57
2022-03
0
5.38
2022-04
0
1.6
2022-05
0
4.57
2022-06
0
2.6
2022-07
0
2
2022-08
0
2.33
2022-09
0
2.22
2022-10
0
2
2022-11
0
2
2022-12
0
2.33
2023-01
0
2.38
2023-02
0
4
2023-03
0
4
2023-04
0
1.6
2023-05
0
2.27
2023-06
0
2.63
2023-07
0
3.25
2023-08
0
2.17
2023-09
0
1.33
2023-10
0
1.67
2023-11
0
4.5
2023-12
0
9.75
2024-01
0
8.29
2024-02
0
7
2024-03
0
5.29
2024-04
0
7
2024-05
0
9.38
2024-06
0
8.71
2024-07
0
5.06
2024-08
0
4.11
2024-09
0
2.45
2024-10
0
3.79
2024-11
0
4.25
2024-12
0
4.07
2025-01
0
4.18
2025-02
0
3.92
2025-03
0
3.5
2025-04
0
5.07
2025-05
0
6.88
2025-06
0
3.64
2025-07
0
5.75
2025-08
0
4.89
2025-09
0
3.45
2025-10
0
3.25
2025-11
0
5.59
2025-12
0
5.32
2026-01
0
5.85
2026-02
0
7.56
2026-03
0
5.1
2026-04
0
6.33
2026-05
0
7.96
2026-06
0
7.08
This device (reports/month)Average device in DSH, DXN (reports/device/month)