510(k) Report

FDA applicant

Cuattro, LLC

Hoptacong, NJ2 decisions2010–20161 recall

FDA records 2 decisions for Cuattro, LLC (Hoptacong, NJ) from 2010 to 2016: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPR (System, X-Ray, Stationary). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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 Cuattro, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12016: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2010high 1 (2019) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Cuattro, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision
  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K093480Cuattro UnomdCuattro, LLC · 20101cites it

What has FDA decided for it lately?

  • K161937CuattroDRCuattro, LLC · 20161 recall
  • K093480Cuattro UnomdCuattro, LLC · 2010

All 2 as Cuattro, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K161937CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0Oct 15, 2019Class II