Vivo 45 LS— 510(k) K233452

Clearance details

Applicant

Breas Medical AB

Product code

Code NOU

Device class

Class 2

Regulation

21 CFR 868.5895

Advisory panel

Anesthesiology

Date received

2023-10-20

Decision date

2025-01-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Molnlycke, SE

• K193586 — Vivo 45 LS2021-01-27
• K160481 — Vivo 602016-11-09
• K123144 — VIVO 502013-06-18
• K034032 — PLV CONTINUUM VENTILATOR, MODEL P20002004-03-16
• K022750 — PLV CONTINUUM VENTILATOR, MODEL P10002003-11-20

• K242485 — EveryWare2025-05-20
• K242438 — Clearo2025-05-16
• K240778 — Vivo 1, Vivo 22024-12-13
• K240779 — Vivo 32024-12-13
• K090113 — BREAS VIVO 40 SYSTEM2009-05-14

Death

65

Injury

138

Malfunction

3,664

Other

1

Total

3,868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0405-2024 — with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.Class II·Ongoing·Breas Medical, Inc.·20231013

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233452.