# K913021: Biodex,Model B-2000

- Pathway: 510(k) (Traditional)
- Applicant: Biodex Corp.
- Decided: Oct 3, 1991 after 86 days
- Product code: IKK (System, Isokinetic Testing And Evaluation)
- Device class: 2
- Regulation: 21 CFR 890.1925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP (1995), 1 descendant of its own
- K123746: Ames Therapy Device (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K913021
Methodology: https://510kreport.com/methodology