510(k) Report

FDA applicant

Imtmedical AG

Buchs Sg, CH2 decisions2017–20194 recalls

FDA records 2 decisions for Imtmedical AG (Buchs Sg, CH) from 2017 to 2019: 2 510(k) clearances. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 1 predicate, 1 of them its own earlier devices. 4 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 Imtmedical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2023

2019: 12021: 1, 1 Class I2023: 2
2017high 2 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Imtmedical AG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imtmedical AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163127bellavista 1000Imtmedical AG · 20171cites it

What has FDA decided for it lately?

  • K183364BellavistaImtmedical AG · 20191 Class I recall
  • K163127bellavista 1000Imtmedical AG · 20171 recall

All 2 as Imtmedical AG →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K183364bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use VentilatorMay 5, 2023Class II
  • K183364bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use VentilatorMay 5, 2023Class II
  • K183364bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator…Dec 20, 2021Class I
  • K163127bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically…Nov 25, 2019Class II