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Model ECG Cables & Leadwires · SPACELABS HEALTHCARE (WASHINGTON), INC · DI 10841522101830
DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025
UDILibrary device dossier · generated 2026-09-13 · 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
29.54
2019-02
0
26.62
2019-03
0
46.6
2019-04
0
36.6
2019-05
0
27.92
2019-06
0
24.23
2019-07
0
35.58
2019-08
0
23.54
2019-09
0
37.18
2019-10
0
31.45
2019-11
0
36.5
2019-12
0
30.36
2020-01
0
33.2
2020-02
0
36.5
2020-03
0
30.92
2020-04
0
17.64
2020-05
0
17.38
2020-06
0
21.31
2020-07
0
22.29
2020-08
0
23.92
2020-09
0
20.64
2020-10
0
24.83
2020-11
0
29.46
2020-12
0
17.53
2021-01
0
12
2021-02
0
19.93
2021-03
0
22.62
2021-04
0
25.63
2021-05
0
16.4
2021-06
0
18.06
2021-07
0
13.76
2021-08
0
12.94
2021-09
0
22.47
2021-10
0
9.41
2021-11
0
13.93
2021-12
0
11.22
2022-01
0
17.93
2022-02
0
13
2022-03
0
12.65
2022-04
0
18.07
2022-05
0
12.93
2022-06
0
11.5
2022-07
0
9.47
2022-08
0
14.15
2022-09
0
15
2022-10
0
27.44
2022-11
0
12.19
2022-12
0
14.57
2023-01
0
12.25
2023-02
0
15.25
2023-03
0
19.33
2023-04
0
10.44
2023-05
0
18.07
2023-06
0
13.91
2023-07
0
14.71
2023-08
0
18.16
2023-09
0
12.93
2023-10
0
12.94
2023-11
0
17.92
2023-12
0
10.5
2024-01
0
16.75
2024-02
0
13.86
2024-03
0
12.38
2024-04
0
11.71
2024-05
0
20.27
2024-06
0
15.5
2024-07
0
10.15
2024-08
0
12.55
2024-09
0
11.48
2024-10
0
22.24
2024-11
0
13.13
2024-12
0
9
2025-01
0
16.05
2025-02
0
10.83
2025-03
0
15.8
2025-04
0
7.92
2025-05
0
15.64
2025-06
0
12.73
2025-07
0
15.76
2025-08
0
18.08
2025-09
0
8.5
2025-10
0
13.95
2025-11
0
14.96
2025-12
0
13.38
2026-01
0
14.95
2026-02
0
11.67
2026-03
0
17.35
2026-04
0
20.43
2026-05
0
14.89
2026-06
0
16.74
This device (reports/month)Average device in DSI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K103142 — cited as predicate by K112962, K200015
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SPACELABS HEALTHCARE (WASHINGTON), INC