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Nexus TKO®
Model P6882N · NEXUS MEDICAL, LLC · DI 10815879021806
FPA — Set, Administration, Intravascular · Class II · 21 CFR 880.5440
LHI — Set, I.V. Fluid Transfer · Class II · 21 CFR 880.5440
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 (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
4.54
2019-02
0
4.47
2019-03
0
5.2
2019-04
0
5.08
2019-05
0
4.13
2019-06
0
3.65
2019-07
0
3.88
2019-08
0
3.66
2019-09
0
3.71
2019-10
0
4.35
2019-11
0
3.63
2019-12
0
4.2
2020-01
0
3.98
2020-02
0
4.3
2020-03
0
4.48
2020-04
0
4.8
2020-05
0
4.99
2020-06
0
4.25
2020-07
0
3.6
2020-08
0
4.34
2020-09
0
4.2
2020-10
0
3.75
2020-11
0
4.42
2020-12
0
4.41
2021-01
0
4.05
2021-02
0
4.15
2021-03
0
3.28
2021-04
0
3.7
2021-05
0
5.11
2021-06
0
4.95
2021-07
0
4.67
2021-08
0
4.19
2021-09
0
3.4
2021-10
0
3.28
2021-11
0
4.45
2021-12
0
4.45
2022-01
0
4.84
2022-02
0
3.99
2022-03
0
4.62
2022-04
0
5.35
2022-05
0
5.47
2022-06
0
5.26
2022-07
0
4.15
2022-08
0
4.49
2022-09
0
5.42
2022-10
0
4.51
2022-11
0
3.96
2022-12
0
3.61
2023-01
0
4.66
2023-02
0
3.73
2023-03
0
4.41
2023-04
0
3.3
2023-05
0
4.13
2023-06
0
3.72
2023-07
0
3.86
2023-08
0
3.97
2023-09
0
3.68
2023-10
0
3.46
2023-11
0
3.64
2023-12
0
3.32
2024-01
0
3.25
2024-02
0
3.93
2024-03
0
3.27
2024-04
0
3.98
2024-05
0
15.25
2024-06
0
42.47
2024-07
0
44.69
2024-08
0
30.24
2024-09
0
24.38
2024-10
0
19.7
2024-11
0
20.63
2024-12
0
14.71
2025-01
0
13.36
2025-02
0
10.63
2025-03
0
12.08
2025-04
0
10.86
2025-05
0
12.35
2025-06
0
8.58
2025-07
0
8.78
2025-08
0
9.49
2025-09
0
7.23
2025-10
0
8.21
2025-11
0
10.19
2025-12
0
6.86
2026-01
0
8.55
2026-02
0
7.7
2026-03
0
31.74
2026-04
0
70.86
2026-05
0
63.41
2026-06
0
69.9
This device (reports/month)Average device in FPA, LHI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — NEXUS MEDICAL, LLC