510(k) Report

FDA applicant

Breas Medical AB

Molnlycke, SE15 decisions2006–20255 recalls

FDA records 15 decisions for Breas Medical AB (Molnlycke, SE) from 2006 to 2025: 15 510(k) clearances. Most are in product codes MNT (Continuous, Minimal Ventilatory Support…) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 19 predicates, 4 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Breas Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 12008: 12009: 12016: 12021: 12024: 22025: 3
2007high 3 (2025) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2024

2018: 12020: 12022: 12023: 12024: 1, 1 Class I
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Breas Medical AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator4decisions
  • BZDVentilator, Non-Continuous (Respirator)3decisions
  • NOUContinuous, Ventilator, Home Use3decisions
  • MNSVentilator, Continuous, Non-Life-Supporting2decisions
  • MODAccessory To Continuous Ventilator (Respirator)1decision
  • NHJDevice, Positive Pressure Breathing, Intermittent1decision

Also: BTT (1).

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160481Vivo 60Breas Medical AB · 20163cite it
  • K063476Breas Isleep 20IBreas Medical AB · 20072cite it
  • K193586Vivo 45 LSBreas Medical AB · 20212cite it
  • K090113Breas Vivo 40 SystemBreas Medical AB · 20092cite it
  • K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 20081cites it
  • K053607Breas Vivo 40 SystemBreas Medical AB · 20061cites it

What has FDA decided for it lately?

  • K242485EveryWareBreas Medical AB · 2025
  • K242438ClearoBreas Medical AB · 2025
  • K233452Vivo 45 LSBreas Medical AB · 20251 recall
  • K240779Vivo 3Breas Medical AB · 2024
  • K240778Vivo 1, Vivo 2Breas Medical AB · 2024
  • K193586Vivo 45 LSBreas Medical AB · 20211 Class I recall
  • K160481Vivo 60Breas Medical AB · 20162 recalls
  • K090113Breas Vivo 40 SystemBreas Medical AB · 2009

All 15 as Breas Medical AB →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K193586Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or…Jul 25, 2024Class I
  • K193586with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653…Oct 13, 2023Class II
  • K193586Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support…Jun 2, 2022Class II
  • K160481Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory…Jan 28, 2020Class II
  • K160481Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide…May 8, 2018Class III