510(k) Report

FDA applicant

Siemens Elema AB

Mchenry, IL63 decisions1978–20037 recalls

FDA records 63 decisions for Siemens Elema AB (Mchenry, IL) from 1978 to 2003: 63 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and DXY (Implantable Pacemaker Pulse-Generator). Its devices cite 3 predicates, 1 of them its own earlier devices. 7 recalls are 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 AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Elema AB since 2007.

Recalls per year

1in 2013

2008: 12009: 22013: 1
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use15decisions
  • DXYImplantable Pacemaker Pulse-Generator15decisions
  • DTBPermanent Pacemaker Electrode3decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation2decisions
  • DQKComputer, Diagnostic, Programmable2decisions
  • DPSElectrocardiograph2decisions

Also: CAF (2), BTI (2), BYD (2), BZN (1), CCK (1), DTD (1).

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 1 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.

  • K970839Servo Ventilator 300ASiemens Elema AB · 19978cite it
  • K010925Servoi Ventilator System, Model 64 87 800 E407ESiemens Elema AB · 20014cite it
  • K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 19963cite it
  • K811102Siemens-Elema AB Servo Ventilator 900 CSiemens Elema AB · 19812cite it
  • K841529Siemens-Elema Ventilator 900CSiemens Elema AB · 19842cite it
  • K023354Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB · 20032cite it

What has FDA decided for it lately?

  • K023354Compressor Mini, 115 V, Model 64 81 779 EH81ESiemens Elema AB · 20031 recall
  • K010923Kion Anaesthesia System, Model 65 03 879 E392ESiemens Elema AB · 2002
  • K010925Servoi Ventilator System, Model 64 87 800 E407ESiemens Elema AB · 20011 recall
  • K002137Cathcor DesktopSiemens Elema AB · 20001 recall
  • K001315Modification to Kion Anesthesia SystemSiemens Elema AB · 2000
  • K970839Servo Ventilator 300ASiemens Elema AB · 19974 recalls
  • K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
  • K960168Siemens Servo Screen 390 and Servo Computer Module 990Siemens Elema AB · 1996

All 63 as Siemens Elema AB →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K023354Compressor Mini To provide a supply of dry, filtered compressed air for a medical…Dec 5, 2013Class II
  • K902859Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB,Nov 17, 2009
  • K902859Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is…Mar 23, 2009
  • K970839SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is…Dec 19, 2008
  • K010925Ventilator System SERVO-i V3.1 PC1777 Maquet Critical CareMay 23, 2006
  • K902859Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action…Jan 3, 2005