# Biodex Medical Systems, Inc.

- Location (FDA's records): Shirley, NY
- FDA decisions: 9 (1994–2009): 9 510(k) clearances
- Product codes: BXB (3), KHX (1), IXR (1), KPT (1), MMK (1), IPF (1), IKK (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biodex Corp.: 2 (https://510kreport.com/company/biodex)
- Atomic Products Corp.: 1 (https://510kreport.com/company/atomic-products)
- Capintec, Inc.: 1 (https://510kreport.com/company/capintec)
- Cybex: 1 (https://510kreport.com/company/cybex)

## Firms that cite its devices most
- Otto Bock, Austria GmbH: 1 (https://510kreport.com/company/otto-bock-austria)
- Ames Technology, Inc.: 1 (https://510kreport.com/company/ames-technology)
- Compex S.A.: 1 (https://510kreport.com/company/compex)

## Its most-cited devices
- K940301: Compex 2 (1994), cited by 2
- K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP (1995), cited by 1

## Recent decisions
- K090296: Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336 (Feb 19, 2009)
- K063666: Sharps Container, Model 039-413 (Jan 25, 2007)
- K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP (Nov 16, 1995)
- K950981: Ultra-Pro Ultrasound Scanning Table Model #056-650 (Apr 3, 1995)
- K942694: Stability System (110V) Model 945-300; Stability System (220V) Model #945-302 (Mar 10, 1995)
- K940301: Compex 2 (Dec 28, 1994)
- K935061: Lower Body Cycles (Sep 16, 1994)
- K935520: Upper Body Cycles (110 Volt)/(220 Volt) (Sep 16, 1994)

Source page: https://510kreport.com/company/biodex-medical-systems