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Vivo 50
Model US · Breas Medical AB · DI 07321822151163
NOU — Continuous, Ventilator, Home Use · Class II · 21 CFR 868.5895
UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2014-11-07
Z-2094-2015
Class II
Terminated
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
k number procode
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
16.72
2019-02
0
19
2019-03
0
11.14
2019-04
0
12.86
2019-05
0
13.64
2019-06
0
10.23
2019-07
0
18
2019-08
0
12.69
2019-09
0
13.4
2019-10
0
15.25
2019-11
0
16.67
2019-12
0
19.22
2020-01
0
15.69
2020-02
0
18.64
2020-03
0
14.15
2020-04
0
14.79
2020-05
0
10
2020-06
0
10.08
2020-07
0
14.6
2020-08
0
12.5
2020-09
0
13.67
2020-10
0
19.68
2020-11
0
15.5
2020-12
0
22.05
2021-01
0
18.68
2021-02
0
19.35
2021-03
0
17.17
2021-04
0
15.61
2021-05
0
13
2021-06
0
20.28
2021-07
0
14
2021-08
0
18.74
2021-09
0
15.69
2021-10
0
22.28
2021-11
0
22
2021-12
0
14.33
2022-01
0
10.9
2022-02
0
13.37
2022-03
0
28.63
2022-04
0
13.43
2022-05
0
13.81
2022-06
0
17.38
2022-07
0
11.36
2022-08
0
14.48
2022-09
0
26
2022-10
0
27.03
2022-11
0
17.36
2022-12
0
22.09
2023-01
0
18.39
2023-02
0
19.58
2023-03
0
21.68
2023-04
0
18.29
2023-05
0
15.39
2023-06
0
12.4
2023-07
0
13.23
2023-08
0
21.18
2023-09
0
19.14
2023-10
0
17.39
2023-11
0
22.07
2023-12
0
21.39
2024-01
0
36.09
2024-02
0
25.91
2024-03
0
22.25
2024-04
0
19.35
2024-05
0
23.16
2024-06
0
21.88
2024-07
0
27.58
2024-08
0
23.72
2024-09
0
35.31
2024-10
0
47.65
2024-11
0
43.38
2024-12
0
28.05
2025-01
0
37.22
2025-02
0
30.5
2025-03
0
41.11
2025-04
0
34.49
2025-05
0
38.1
2025-06
0
27.49
2025-07
0
26.1
2025-08
0
23.76
2025-09
0
26.07
2025-10
0
22.55
2025-11
0
27.57
2025-12
0
26.72
2026-01
0
19.33
2026-02
0
24
2026-03
0
32.31
2026-04
0
50.65
2026-05
0
28.68
2026-06
0
26.9
This device (reports/month)Average device in NOU (reports/device/month)
Regulatory clearances
K123144 SESE 2013-06-18 (k number procode)
Predicate lineage
K123144 — cited as predicate by K160481
Lineage extracted from public 510(k) summary text (heuristic).