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Test Lung Quick Release Kit
Model KIT-0012 · FLIGHT MEDICAL INNOVATIONS LTD · DI 07290017856704
CBK — Ventilator, Continuous, Facility Use · Class II · 21 CFR 868.5895
NOU — Continuous, Ventilator, Home Use · Class II · 21 CFR 868.5895
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
10.84
2019-02
0
11.49
2019-03
0
8.54
2019-04
0
9.55
2019-05
0
7.9
2019-06
0
9.82
2019-07
0
10.78
2019-08
0
10.74
2019-09
0
10.14
2019-10
0
8.79
2019-11
0
9.35
2019-12
0
10.18
2020-01
0
9.64
2020-02
0
9.97
2020-03
0
9.08
2020-04
0
11.87
2020-05
0
8.7
2020-06
0
8.47
2020-07
0
9.39
2020-08
0
9.17
2020-09
0
9.82
2020-10
0
12.72
2020-11
0
11.18
2020-12
0
13.25
2021-01
0
11.68
2021-02
0
12.11
2021-03
0
13.43
2021-04
0
11.7
2021-05
0
10.4
2021-06
0
13.22
2021-07
0
10.52
2021-08
0
13.79
2021-09
0
12.45
2021-10
0
14.31
2021-11
0
13.78
2021-12
0
12.08
2022-01
0
9.75
2022-02
0
12.46
2022-03
0
19.73
2022-04
0
12.13
2022-05
0
13.42
2022-06
0
14.74
2022-07
0
10.04
2022-08
0
12.12
2022-09
0
15.96
2022-10
0
18.51
2022-11
0
14.68
2022-12
0
18.38
2023-01
0
15.12
2023-02
0
19.19
2023-03
0
23.51
2023-04
0
21.67
2023-05
0
20.5
2023-06
0
18.45
2023-07
0
21.7
2023-08
0
28.67
2023-09
0
27.44
2023-10
0
25.42
2023-11
0
30.96
2023-12
0
27.49
2024-01
0
27.92
2024-02
0
24.3
2024-03
0
26.6
2024-04
0
20.07
2024-05
0
22.17
2024-06
0
20.45
2024-07
0
26.46
2024-08
0
25.34
2024-09
0
31.45
2024-10
0
40.31
2024-11
0
36.05
2024-12
0
28.56
2025-01
0
33.35
2025-02
0
27.94
2025-03
0
34.01
2025-04
0
30.63
2025-05
0
31.13
2025-06
0
26.4
2025-07
0
24.44
2025-08
0
22.33
2025-09
0
24.09
2025-10
0
22.75
2025-11
0
25.55
2025-12
0
27.48
2026-01
0
21.5
2026-02
0
23.71
2026-03
0
31.08
2026-04
0
44.09
2026-05
0
25.59
2026-06
0
26.35
This device (reports/month)Average device in CBK, NOU (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — FLIGHT MEDICAL INNOVATIONS LTD