510(k) Report

FDA applicant

Arjohuntleigh Polska SP Z.O.O.

Cardiff, GB2 decisions2012–20140 recalls

FDA records 2 decisions for Arjohuntleigh Polska SP Z.O.O. (Cardiff, GB) from 2012 to 2014: 2 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 3 predicates, 0 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 Arjohuntleigh Polska SP Z.O.O.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012: 12014: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Arjohuntleigh Polska SP Z.O.O. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible2decisions

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.

  • K133119Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 20141cites it

What has FDA decided for it lately?

  • K133119Flowtron ACS800 Pump and Tri Pulse GarmentsArjohuntleigh Polska SP Z.O.O. · 2014
  • K122330Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-SterileArjohuntleigh Polska SP Z.O.O. · 2012

All 2 as Arjohuntleigh Polska SP Z.O.O. →

Other applicant names beginning “Arjohuntleigh”

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

Arjohuntleigh, Inc. 1