# IKK: System, Isokinetic Testing And Evaluation

- Device class: 2; regulation: 21 CFR 890.1925; FDA's rule: 510(k) exempt
- FDA decisions: 61
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 14
- 1987: 4
- 1988: 6
- 1989: 3
- 1990: 9
- 1991: 5
- 1992: 6
- 1993: 1
- 1995: 6
- 2013: 1

## Most-cited predicates
- K913021: Biodex,Model B-2000 (1991), cited by 1
- K905525: CYBEX 6000 (1991), cited by 1
- K915648: Biodex System 2 Autoprogram (1992), cited by 1
- K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP (1995), cited by 1

Source page: https://510kreport.com/product-code/IKK
Data by year (CSV): https://510kreport.com/product-code/IKK.csv