510(k) Report

FDA applicant

Medflex International, Inc.

West Cadwell, NJ1 decision1985–19850 recalls

FDA records 1 decision for Medflex International, Inc. (West Cadwell, NJ) in 1985: 1 510(k) clearance. All are in product code FJK (Set, Tubing, Blood, With And Without…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Medflex International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

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.

  • K852605Blood Tubing SetMedflex International, Inc. · 19851cites it

What has FDA decided for it lately?

  • K852605Blood Tubing SetMedflex International, Inc. · 1985

The one decision as Medflex International, Inc. →