510(k) Report

FDA applicant

Draeger Medical Infant Care, Inc.

Hatboro, PA2 decisions2005–20061 recall

FDA records 2 decisions for Draeger Medical Infant Care, Inc. (Hatboro, PA) from 2005 to 2006: 2 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and MQM (Bilirubin (Total And Unbound) In The Neonate…). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Draeger Medical Infant Care, Inc. since 2007.

Recalls per year

1in 2018

2018: 1, 1 Class I
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Draeger Medical Infant Care, 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?

  • FMZIncubator, Neonatal1decision
  • MQMBilirubin (Total And Unbound) In The Neonate Test System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K042522Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 20051cites it

What has FDA decided for it lately?

  • K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc. · 2006
  • K042522Jaundice Meter, Model JM 103Draeger Medical Infant Care, Inc. · 20051 Class I recall

All 2 as Draeger Medical Infant Care, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042522Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or…May 15, 2018Class I

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 Sytems, Inc. 2Draeger Medical AG & Co. Kgaa 1