510(k) Report

FDA applicant

J-Tech Medical, Inc.

Crofton, MD2 decisions1998–19980 recalls

FDA records 2 decisions for J-Tech Medical, Inc. (Crofton, MD) in 1998: 2 510(k) clearances. Most are in product codes LXM (Manipulator, Plunger-Like Joint) and HRW (Dynamometer, Nonpowered). 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, orthopedic panel, where it files most

How often FDA has decided J-Tech Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for J-Tech Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • LXMManipulator, Plunger-Like Joint1decision
  • HRWDynamometer, Nonpowered1decision

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.

  • K971407Jtech Commander and AlgometerJ-Tech Medical, Inc. · 19981cites it

What has FDA decided for it lately?

  • K971407Jtech Commander and AlgometerJ-Tech Medical, Inc. · 1998
  • K974376Jtech Adjuster Reflex GunJ-Tech Medical, Inc. · 1998

All 2 as J-Tech Medical, Inc. →