510(k) Report

FDA applicant

Futrex, Inc.

Gaithersburg, MD4 decisions1995–20150 recalls

FDA records 4 decisions for Futrex, Inc. (Gaithersburg, MD) from 1995 to 2015: 4 510(k) clearances. Most are in product codes DSB (Plethysmograph, Impedance) and MNW (Analyzer, Body Composition). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • DSBPlethysmograph, Impedance2decisions
  • MNWAnalyzer, Body Composition1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

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 2 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.

  • K963271Futrex-6100/XLFutrex, Inc. · 19982cite it

What has FDA decided for it lately?

  • K143108HealthGuard-15Futrex, Inc. · 2015
  • K963271Futrex-6100/XLFutrex, Inc. · 1998
  • K922601Futrex-5000AFutrex, Inc. · 1995
  • K922600Futrex-5000Futrex, Inc. · 1995

All 4 as Futrex, Inc. →