510(k) Report

FDA applicant

Siemens-Elema Ventilation Systems

Schaumberg, IL1 decision1989–19891 recall

FDA records 1 decision for Siemens-Elema Ventilation Systems (Schaumberg, IL) in 1989: 1 510(k) clearance. All are in product code CBK (Ventilator, Continuous, Facility Use). 1 recall is linked to its devices.

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 Siemens-Elema Ventilation Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens-Elema Ventilation Systems since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Siemens-Elema Ventilation Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siemens-Elema Ventilation Systems’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 Use1decision

What has FDA decided for it lately?

  • K884520Servo Ventilator 900ESiemens-Elema Ventilation Systems · 19891 recall

The one decision as Siemens-Elema Ventilation Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K871254Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, SwedenNov 17, 2009