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500ml Lock Box Kit
Model 190-900PXCV · CME AMERICA LLC · DI B101190900PXCV0
FRN — Pump, Infusion · Class II · 21 CFR 880.5725
MEA — Pump, Infusion, Pca · Class II · 21 CFR 880.5725
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
10.37
2019-02
0
12.74
2019-03
0
13.37
2019-04
0
13.65
2019-05
0
12.57
2019-06
0
10.98
2019-07
0
11.98
2019-08
0
16.96
2019-09
0
13.23
2019-10
0
13.96
2019-11
0
17.59
2019-12
0
23.39
2020-01
0
13.78
2020-02
0
19.94
2020-03
0
17.67
2020-04
0
18.34
2020-05
0
30.67
2020-06
0
18.59
2020-07
0
24.72
2020-08
0
30.74
2020-09
0
82.2
2020-10
0
101.16
2020-11
0
218.82
2020-12
0
450.51
2021-01
0
289.64
2021-02
0
116.58
2021-03
0
77.72
2021-04
0
78.32
2021-05
0
73.49
2021-06
0
75.39
2021-07
0
89.59
2021-08
0
136.14
2021-09
0
160.87
2021-10
0
323.94
2021-11
0
390.58
2021-12
0
1177.92
2022-01
0
2363.61
2022-02
0
1522.12
2022-03
0
2182.7
2022-04
0
2258.67
2022-05
0
1793.85
2022-06
0
1744.23
2022-07
0
825.21
2022-08
0
220.08
2022-09
0
272.21
2022-10
0
259.13
2022-11
0
244.2
2022-12
0
226.13
2023-01
0
120.69
2023-02
0
244.68
2023-03
0
289.33
2023-04
0
245.62
2023-05
0
220.62
2023-06
0
272.84
2023-07
0
267.05
2023-08
0
265.14
2023-09
0
220.36
2023-10
0
124.15
2023-11
0
124.03
2023-12
0
65.99
2024-01
0
61.21
2024-02
0
90.75
2024-03
0
69.27
2024-04
0
72.14
2024-05
0
39.67
2024-06
0
44.34
2024-07
0
41.78
2024-08
0
35.7
2024-09
0
43.8
2024-10
0
46.17
2024-11
0
50.38
2024-12
0
45.86
2025-01
0
56.9
2025-02
0
49.38
2025-03
0
70.74
2025-04
0
62.71
2025-05
0
77.12
2025-06
0
81.57
2025-07
0
109.23
2025-08
0
80.28
2025-09
0
78.74
2025-10
0
83.26
2025-11
0
75.9
2025-12
0
84.61
2026-01
0
68.04
2026-02
0
77.52
2026-03
0
84.18
2026-04
0
134.17
2026-05
0
285.47
2026-06
0
298.8
This device (reports/month)Average device in FRN, MEA (reports/device/month)