510(k) Report

FDA applicant

Stortford Medical, LLC

West Windsor, NJ2 decisions2009–20171 recall

FDA records 2 decisions for Stortford Medical, LLC (West Windsor, NJ) from 2009 to 2017: 2 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and OMP (Negative Pressure Wound Therapy Powered…). Its devices cite 3 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Stortford Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12017: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2009high 1 (2012) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Stortford Medical, 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?

  • JOWSleeve, Limb, Compressible1decision
  • OMPNegative Pressure Wound Therapy Powered Suction Pump1decision

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 3 times; 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.

  • K090308Restep Dvy System, Model RSP-101Stortford Medical, LLC · 20093cite it

What has FDA decided for it lately?

  • K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC · 2017
  • K090308Restep Dvy System, Model RSP-101Stortford Medical, LLC · 20091 recall

All 2 as Stortford Medical, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090308STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT)…Aug 30, 2012Class II