510(k) Report

FDA applicant

Xtract Solutions, LLC

Grants Pass, OR2 decisions2009–20110 recalls

FDA records 2 decisions for Xtract Solutions, LLC (Grants Pass, OR) from 2009 to 2011: 2 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Xtract Solutions”.

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 Xtract Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12011: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Xtract Solutions, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K091200Xtract Syringe KeysXtract Solutions, LLC · 20091cites it

What has FDA decided for it lately?

  • K112475Xtract Syringe Key SystemXtract Solutions · 2011
  • K091200Xtract Syringe KeysXtract Solutions, LLC · 2009

The one decision as Xtract Solutions, LLC →The one decision as Xtract Solutions →