# KNN: Components, Wheelchair

- Device class: 1; regulation: 21 CFR 890.3920; FDA's rule: 510(k) exempt
- FDA decisions: 64
- 510(k) review time 2021–2025: median 256 days (middle half 256–256)
- Recalls: 3 (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: 7
- 1987: 2
- 1988: 7
- 1989: 3
- 1990: 3
- 1991: 11
- 1992: 4
- 1993: 6
- 1994: 6
- 2022: 1

## Most-cited predicates
- K863385: (Roth)Spiral Rotating Prostatic Biopsy Needle (1986), cited by 1
- K942312: Alden Lineage Wheelchair Cushion (1994), cited by 1
- K923364: Tilt Adjustable Sliding Back Recline Seating Syst (1993), cited by 1

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