510(k) Report

FDA applicant

Cybex

Ronkonkoma, NY9 decisions1984–19950 recalls

FDA records 9 decisions for Cybex (Ronkonkoma, NY) from 1984 to 1995: 9 510(k) clearances. Most are in product codes IKK (System, Isokinetic Testing And Evaluation) and ISD (Exerciser, Measuring). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Cybex since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IKKSystem, Isokinetic Testing And Evaluation7decisions
  • ISDExerciser, Measuring1decision
  • KQXGoniometer, Ac-Powered1decision

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.

  • K905525CYBEX 6000Cybex · 19911cites it

What has FDA decided for it lately?

  • K950095CYBEX 770Cybex · 1995
  • K905525CYBEX 6000Cybex · 1991
  • K881681Cybex Back Testing and Rehabilitation SystemCybex · 1990
  • K881676Linear Lift DeviceCybex · 1990
  • K894154Metabolic SystemsCybex · 1989
  • K873599EDI 320Cybex · 1987
  • K872911CYBEX 340Cybex · 1987
  • K844368Linear Lift DeviceCybex · 1985

All 9 as Cybex →