510(k) Report

FDA applicant

Draeger Medical, Inc.

Telford, PA94 decisions1977–201434 recalls

FDA records 94 decisions for Draeger Medical, Inc. (Telford, PA) from 1977 to 2014: 94 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 106 predicates, 35 of them its own earlier devices. 34 recalls are linked to its devices, 16 Class I.

FDA’s records also spell it “Draeger Medical AG & Co. KG”, “Draeger Medical GmbH”, “Draeger Medical B.V.”.

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 Draeger Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2008: 72009: 12010: 32012: 12013: 12014: 2
2007high 7 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 32009: 22010: 22013: 1, 1 Class I2015: 4, 3 Class I2016: 12018: 10, 4 Class I2021: 12022: 1, 1 Class I2023: 3, 3 Class I2024: 1, 1 Class I2025: 2, 2 Class I2026 (partial year): 1, 1 Class I
2007high 10 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Draeger Medical, Inc.’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?

  • BSZGas-Machine, Anesthesia37decisions
  • CBKVentilator, Continuous, Facility Use14decisions
  • CADVaporizer, Anesthesia, Non-Heated7decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase6decisions
  • BYEAttachment, Breathing, Positive End Expiratory Pressure4decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive3decisions

Also: CAP (3), CBN (2), FLL (2), BYR (1), CBS (1), FMT (1).

Whose devices does it build on?

Its devices cite 106 predicates; 35 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 63 times; 35 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.

  • K012139Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 20025cite it
  • K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 20044cite it
  • K042607Primus USDraeger Medical, Inc. · 20044cite it
  • K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc. · 19992cite it
  • K011404Fabius GS Anesthesia System, Model Fabius GSDraeger Medical, Inc. · 20022cite it
  • K930351Narkomed 2C Anesthesia SystemDraeger Medical, Inc. · 19932cite it

What has FDA decided for it lately?

  • K121886Savina 300 Savina 300, Country VariantsDraeger Medical GmbH · 2014
  • K133886Perseus A500Draeger Medical GmbH · 20142 Class I recalls
  • K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
  • K103035Smartpilot View Model MK04500Draeger Medical GmbH · 2012
  • K102618Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG · 2010
  • K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG · 20101 Class I recall
  • K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG · 2010
  • K092999NBP CuffDraeger Medical AG & Co. KG · 2009

All 78 as Draeger Medical, Inc. →All 10 as Draeger Medical AG & Co. KG →All 4 as Draeger Medical GmbH →

What has been recalled?

34 recalls linked to its devices; the latest:

  • K092029VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable…Sep 3, 2026Class I
  • K971923Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.Nov 24, 2025Class I
  • K971923Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.Nov 24, 2025Class I
  • K133886Dr¿ger Perseus A500 Anesthesia WorkstationMar 20, 2024Class I
  • K072885Carina Sub-Acute Care VentilatorJul 12, 2023Class I
  • K081743NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size…Jan 23, 2023Class I

Other applicant names beginning “Draeger”

FDA records each applicant name separately; these may or may not be the same firm.

Draeger Medical Systems, Inc. 49Draeger Medical Infant Care, Inc. 2Draeger Medical Sytems, Inc. 2Draeger Medical AG & Co. Kgaa 1