510(k) Report

FDA applicant

The Newman Group, LLC

Lake Bluff, IL2 decisions2006–20090 recalls

FDA records 2 decisions for The Newman Group, LLC (Lake Bluff, IL) from 2006 to 2009: 2 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and KNG (Monitor, Ultrasonic, Fetal). No 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, radiology panel, where it files most

How often FDA has decided The Newman Group, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Newman Group, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • KNGMonitor, Ultrasonic, Fetal1decision

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.

  • K090465Digdop Ultrasound SystemThe Newman Group, LLC · 20091cites it

What has FDA decided for it lately?

  • K090465Digdop Ultrasound SystemThe Newman Group, LLC · 2009
  • K061091Babybeat CordlessThe Newman Group, LLC · 2006

All 2 as The Newman Group, LLC →

Other applicant names beginning “The”

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

Newman Medical 1Newman Assoc. 1