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ARES 620 Unicorder System
Model 620 · Watermark Medical, Inc. · DI 00854485007012
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
MNR — Ventilatory Effort Recorder · Class II · 21 CFR 868.2375
NFB — Conserver, Oxygen · Class II · 21 CFR 868.5905
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
2.71
2019-02
0
3.5
2019-03
0
2.8
2019-04
0
1.75
2019-05
0
2.27
2019-06
0
1.56
2019-07
0
1.53
2019-08
0
3.77
2019-09
0
2.71
2019-10
0
3.56
2019-11
0
3.79
2019-12
0
4.23
2020-01
0
2.65
2020-02
0
1.91
2020-03
0
3.24
2020-04
0
2.39
2020-05
0
1.5
2020-06
0
1.59
2020-07
0
2.06
2020-08
0
2.69
2020-09
0
2.65
2020-10
0
3.66
2020-11
0
2.63
2020-12
0
2.42
2021-01
0
1.14
2021-02
0
2
2021-03
0
1.67
2021-04
0
1.82
2021-05
0
1.52
2021-06
0
2.11
2021-07
0
2.59
2021-08
0
2.24
2021-09
0
3.6
2021-10
0
2.43
2021-11
0
1.79
2021-12
0
1.5
2022-01
0
1.95
2022-02
0
1.76
2022-03
0
1.35
2022-04
0
2.33
2022-05
0
2.69
2022-06
0
2.11
2022-07
0
1.69
2022-08
0
2.16
2022-09
0
2.12
2022-10
0
2.3
2022-11
0
2
2022-12
0
1.87
2023-01
0
2.5
2023-02
0
2
2023-03
0
2.43
2023-04
0
1.8
2023-05
0
2.31
2023-06
0
2.31
2023-07
0
1.73
2023-08
0
2.72
2023-09
0
3.18
2023-10
0
6.98
2023-11
0
5.55
2023-12
0
6.89
2024-01
0
5.22
2024-02
0
6.65
2024-03
0
5.39
2024-04
0
7.76
2024-05
0
7.8
2024-06
0
5.96
2024-07
0
9.32
2024-08
0
12.05
2024-09
0
15.27
2024-10
0
13.26
2024-11
0
11.41
2024-12
0
8.76
2025-01
0
8.47
2025-02
0
16.06
2025-03
0
11.24
2025-04
0
10.76
2025-05
0
8.11
2025-06
0
8.79
2025-07
0
16.07
2025-08
0
8.4
2025-09
0
9.59
2025-10
0
13.79
2025-11
0
11.97
2025-12
0
11.49
2026-01
0
9.23
2026-02
0
8
2026-03
0
11.18
2026-04
0
10.69
2026-05
0
10.77
2026-06
0
12.25
This device (reports/month)Average device in ETN, MNR, NFB (reports/device/month)