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Nexus TKO®
Model P4870 · NEXUS MEDICAL, LLC · DI 10815879021639
FPA — Set, Administration, Intravascular · Class II · 21 CFR 880.5440
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
4.32
2019-02
0
4.03
2019-03
0
4.74
2019-04
0
5.1
2019-05
0
3.97
2019-06
0
3.39
2019-07
0
3.98
2019-08
0
3.94
2019-09
0
3.7
2019-10
0
4.08
2019-11
0
3.41
2019-12
0
3.84
2020-01
0
3.6
2020-02
0
3.87
2020-03
0
3.97
2020-04
0
4.55
2020-05
0
4.61
2020-06
0
4.02
2020-07
0
3.31
2020-08
0
4.06
2020-09
0
3.47
2020-10
0
3.22
2020-11
0
3.92
2020-12
0
3.84
2021-01
0
3.47
2021-02
0
3.74
2021-03
0
2.82
2021-04
0
3.27
2021-05
0
4.43
2021-06
0
4.78
2021-07
0
4.62
2021-08
0
4.08
2021-09
0
3.42
2021-10
0
3.33
2021-11
0
4.85
2021-12
0
4.85
2022-01
0
5.12
2022-02
0
4.38
2022-03
0
4.65
2022-04
0
4.85
2022-05
0
5.43
2022-06
0
5.01
2022-07
0
3.96
2022-08
0
4.48
2022-09
0
5.53
2022-10
0
4.5
2022-11
0
3.52
2022-12
0
3.38
2023-01
0
4.57
2023-02
0
3.56
2023-03
0
4
2023-04
0
3.26
2023-05
0
4.11
2023-06
0
3.51
2023-07
0
3.72
2023-08
0
3.94
2023-09
0
3.5
2023-10
0
3.35
2023-11
0
3.32
2023-12
0
3.01
2024-01
0
3.27
2024-02
0
3.67
2024-03
0
2.86
2024-04
0
3.86
2024-05
0
16.34
2024-06
0
46.94
2024-07
0
48.56
2024-08
0
33.71
2024-09
0
26.3
2024-10
0
20.98
2024-11
0
22.17
2024-12
0
15.83
2025-01
0
14.61
2025-02
0
10.74
2025-03
0
12.89
2025-04
0
11.39
2025-05
0
13.49
2025-06
0
8.87
2025-07
0
8.88
2025-08
0
9.71
2025-09
0
7.34
2025-10
0
8.35
2025-11
0
10.07
2025-12
0
6.57
2026-01
0
8.24
2026-02
0
7.87
2026-03
0
35
2026-04
0
79.08
2026-05
0
71.66
2026-06
0
77.34
This device (reports/month)Average device in FPA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K130416 — cited as predicate by K221518
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — NEXUS MEDICAL, LLC