Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Vivo 45 LS, Vivo 65

Model 006359 · Breas Medical AB · DI 07321820063598

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 2026-09-16 · 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.

112233442019-01: 0 reports for this device; peer average 10.84/device2019-02: 0 reports for this device; peer average 11.49/device2019-03: 0 reports for this device; peer average 8.54/device2019-04: 0 reports for this device; peer average 9.55/device2019-05: 0 reports for this device; peer average 7.9/device2019-06: 0 reports for this device; peer average 9.82/device2019-07: 0 reports for this device; peer average 10.78/device2019-08: 0 reports for this device; peer average 10.74/device2019-09: 0 reports for this device; peer average 10.14/device2019-10: 0 reports for this device; peer average 8.79/device2019-11: 0 reports for this device; peer average 9.35/device2019-12: 0 reports for this device; peer average 10.18/device2020-01: 0 reports for this device; peer average 9.64/device2020-02: 0 reports for this device; peer average 9.97/device2020-03: 0 reports for this device; peer average 9.08/device2020-04: 0 reports for this device; peer average 11.87/device2020-05: 0 reports for this device; peer average 8.7/device2020-06: 0 reports for this device; peer average 8.47/device2020-07: 0 reports for this device; peer average 9.39/device2020-08: 0 reports for this device; peer average 9.17/device2020-09: 0 reports for this device; peer average 9.82/device2020-10: 0 reports for this device; peer average 12.72/device2020-11: 0 reports for this device; peer average 11.18/device2020-12: 0 reports for this device; peer average 13.25/device2021-01: 0 reports for this device; peer average 11.68/device2021-02: 0 reports for this device; peer average 12.11/device2021-03: 0 reports for this device; peer average 13.43/device2021-04: 0 reports for this device; peer average 11.7/device2021-05: 0 reports for this device; peer average 10.4/device2021-06: 0 reports for this device; peer average 13.22/device2021-07: 0 reports for this device; peer average 10.52/device2021-08: 0 reports for this device; peer average 13.79/device2021-09: 0 reports for this device; peer average 12.45/device2021-10: 0 reports for this device; peer average 14.31/device2021-11: 0 reports for this device; peer average 13.78/device2021-12: 0 reports for this device; peer average 12.08/device2022-01: 0 reports for this device; peer average 9.75/device2022-02: 0 reports for this device; peer average 12.46/device2022-03: 0 reports for this device; peer average 19.73/device2022-04: 0 reports for this device; peer average 12.13/device2022-05: 0 reports for this device; peer average 13.42/device2022-06: 0 reports for this device; peer average 14.74/device2022-07: 0 reports for this device; peer average 10.04/device2022-08: 0 reports for this device; peer average 12.12/device2022-09: 0 reports for this device; peer average 15.96/device2022-10: 0 reports for this device; peer average 18.51/device2022-11: 0 reports for this device; peer average 14.68/device2022-12: 0 reports for this device; peer average 18.38/device2023-01: 0 reports for this device; peer average 15.12/device2023-02: 0 reports for this device; peer average 19.19/device2023-03: 0 reports for this device; peer average 23.51/device2023-04: 0 reports for this device; peer average 21.67/device2023-05: 0 reports for this device; peer average 20.5/device2023-06: 0 reports for this device; peer average 18.45/device2023-07: 0 reports for this device; peer average 21.7/device2023-08: 0 reports for this device; peer average 28.67/device2023-09: 0 reports for this device; peer average 27.44/device2023-10: 0 reports for this device; peer average 25.42/device2023-11: 0 reports for this device; peer average 30.96/device2023-12: 0 reports for this device; peer average 27.49/device2024-01: 0 reports for this device; peer average 27.92/device2024-02: 0 reports for this device; peer average 24.3/device2024-03: 0 reports for this device; peer average 26.6/device2024-04: 0 reports for this device; peer average 20.07/device2024-05: 0 reports for this device; peer average 22.17/device2024-06: 0 reports for this device; peer average 20.45/device2024-07: 0 reports for this device; peer average 26.46/device2024-08: 0 reports for this device; peer average 25.34/device2024-09: 0 reports for this device; peer average 31.45/device2024-10: 0 reports for this device; peer average 40.31/device2024-11: 0 reports for this device; peer average 36.05/device2024-12: 0 reports for this device; peer average 28.56/device2025-01: 0 reports for this device; peer average 33.35/device2025-02: 0 reports for this device; peer average 27.94/device2025-03: 0 reports for this device; peer average 34.01/device2025-04: 0 reports for this device; peer average 30.63/device2025-05: 0 reports for this device; peer average 31.13/device2025-06: 0 reports for this device; peer average 26.4/device2025-07: 0 reports for this device; peer average 24.44/device2025-08: 0 reports for this device; peer average 22.33/device2025-09: 0 reports for this device; peer average 24.09/device2025-10: 0 reports for this device; peer average 22.75/device2025-11: 0 reports for this device; peer average 25.55/device2025-12: 0 reports for this device; peer average 27.48/device2026-01: 0 reports for this device; peer average 21.5/device2026-02: 0 reports for this device; peer average 23.71/device2026-03: 0 reports for this device; peer average 31.08/device2026-04: 0 reports for this device; peer average 44.09/device2026-05: 0 reports for this device; peer average 25.59/device2026-06: 0 reports for this device; peer average 26.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01010.84
2019-02011.49
2019-0308.54
2019-0409.55
2019-0507.9
2019-0609.82
2019-07010.78
2019-08010.74
2019-09010.14
2019-1008.79
2019-1109.35
2019-12010.18
2020-0109.64
2020-0209.97
2020-0309.08
2020-04011.87
2020-0508.7
2020-0608.47
2020-0709.39
2020-0809.17
2020-0909.82
2020-10012.72
2020-11011.18
2020-12013.25
2021-01011.68
2021-02012.11
2021-03013.43
2021-04011.7
2021-05010.4
2021-06013.22
2021-07010.52
2021-08013.79
2021-09012.45
2021-10014.31
2021-11013.78
2021-12012.08
2022-0109.75
2022-02012.46
2022-03019.73
2022-04012.13
2022-05013.42
2022-06014.74
2022-07010.04
2022-08012.12
2022-09015.96
2022-10018.51
2022-11014.68
2022-12018.38
2023-01015.12
2023-02019.19
2023-03023.51
2023-04021.67
2023-05020.5
2023-06018.45
2023-07021.7
2023-08028.67
2023-09027.44
2023-10025.42
2023-11030.96
2023-12027.49
2024-01027.92
2024-02024.3
2024-03026.6
2024-04020.07
2024-05022.17
2024-06020.45
2024-07026.46
2024-08025.34
2024-09031.45
2024-10040.31
2024-11036.05
2024-12028.56
2025-01033.35
2025-02027.94
2025-03034.01
2025-04030.63
2025-05031.13
2025-06026.4
2025-07024.44
2025-08022.33
2025-09024.09
2025-10022.75
2025-11025.55
2025-12027.48
2026-01021.5
2026-02023.71
2026-03031.08
2026-04044.09
2026-05025.59
2026-06026.35
This device (reports/month)Average device in CBK, NOU (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K160481 — cites (transitively): K123144 (d1), K133868 (d1), K060647 (d2), K093416 (d2), K083526 (d3) — cited as predicate by K181166, K181170, K193586

K193586 — cites (transitively): K160481 (d1), K181166 (d1), K123144 (d2), K133868 (d2), K091459 (d2), K111610 (d2), K121623 (d2), K151252 (d2), K162877 (d2), K061627 (d3), K083526 (d3), K093416 (d3), K093905 (d3), K060647 (d3), K092847 (d3), K131252 (d3), K070594 (d3), K110398 (d3), K120785 (d3), K121955 (d3), K140179 (d3), K973797 (d3), K100104 (d4), K013931 (d4), K083163 (d4), K002598 (d4), K971749 (d4), K041900 (d5), K071958 (d5) — cited as predicate by K232365, K233452

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Breas Medical AB

  • VAI 2022-08-10 Breas Medical AB · 1 citations
  • VAI 2015-03-05 Breas Medical AB · 2 citations
  • VAI 2010-03-25 Breas Medical AB · 0 citations