510(k) Report

FDA applicant

Draeger Medical Sytems, Inc.

Andover, MA2 decisions2015–20184 recalls

FDA records 2 decisions for Draeger Medical Sytems, Inc. (Andover, MA) from 2015 to 2018: 2 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and FMZ (Incubator, Neonatal). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2019

2017: 32019: 1
2015high 3 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Draeger Medical Sytems, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision
  • FMZIncubator, Neonatal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K172154Isolette 8000 plusDraeger Medical Sytems, Inc. · 20182cite it

What has FDA decided for it lately?

  • K172154Isolette 8000 plusDraeger Medical Sytems, Inc. · 2018
  • K152407Infinity Delta, Infinity Delta XL, Infinity KappaDraeger Medical Sytems, Inc. · 20154 recalls

All 2 as Draeger Medical Sytems, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K152407Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa)…Feb 8, 2019Class II
  • K152407Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi…Mar 28, 2017Class II
  • K152407Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus…Mar 28, 2017Class II
  • K152407Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus…Mar 28, 2017Class II

Other applicant names beginning “Draeger”

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

Draeger Medical, Inc. 94Draeger Medical Systems, Inc. 49Draeger Medical Infant Care, Inc. 2Draeger Medical AG & Co. Kgaa 1