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7500 V MASK
Model 7500 · HANS RUDOLPH, INC. · DI 00874750000005
CBK — Ventilator, Continuous, Facility Use · Class II · 21 CFR 868.5895
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
9.25
2019-02
0
9.79
2019-03
0
7.91
2019-04
0
8.73
2019-05
0
6.84
2019-06
0
9.72
2019-07
0
9.62
2019-08
0
10.36
2019-09
0
9.65
2019-10
0
7.76
2019-11
0
8.16
2019-12
0
8.97
2020-01
0
8.33
2020-02
0
8.55
2020-03
0
8.17
2020-04
0
11.29
2020-05
0
8.46
2020-06
0
8.16
2020-07
0
8.38
2020-08
0
8.6
2020-09
0
8.96
2020-10
0
10.95
2020-11
0
10.14
2020-12
0
11.4
2021-01
0
10.2
2021-02
0
10.45
2021-03
0
12.48
2021-04
0
10.61
2021-05
0
9.68
2021-06
0
11.82
2021-07
0
9.72
2021-08
0
12.31
2021-09
0
11.37
2021-10
0
12.21
2021-11
0
11.95
2021-12
0
11.43
2022-01
0
9.38
2022-02
0
12.15
2022-03
0
16.94
2022-04
0
11.72
2022-05
0
13.28
2022-06
0
13.98
2022-07
0
9.6
2022-08
0
11.45
2022-09
0
13.34
2022-10
0
15.93
2022-11
0
13.96
2022-12
0
17.17
2023-01
0
14.17
2023-02
0
19.05
2023-03
0
24.08
2023-04
0
22.65
2023-05
0
22.11
2023-06
0
20.59
2023-07
0
24.72
2023-08
0
31.19
2023-09
0
29.85
2023-10
0
27.83
2023-11
0
33.76
2023-12
0
29.66
2024-01
0
25.36
2024-02
0
23.67
2024-03
0
28.16
2024-04
0
20.31
2024-05
0
21.81
2024-06
0
19.99
2024-07
0
26.01
2024-08
0
25.98
2024-09
0
30.07
2024-10
0
37.26
2024-11
0
32.89
2024-12
0
28.77
2025-01
0
31.7
2025-02
0
26.93
2025-03
0
31.03
2025-04
0
28.84
2025-05
0
28.02
2025-06
0
25.91
2025-07
0
23.73
2025-08
0
21.74
2025-09
0
23.18
2025-10
0
22.85
2025-11
0
24.56
2025-12
0
27.8
2026-01
0
22.43
2026-02
0
23.58
2026-03
0
30.54
2026-04
0
40.9
2026-05
0
24.14
2026-06
0
26.11
This device (reports/month)Average device in CBK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — HANS RUDOLPH, INC.