# LDK: Device, Sensing, Optical Contour

- Device class: U; regulation: 21 CFR —
- FDA decisions: 8
- 510(k) review time 2021–2025: median 178 days (middle half 134–223)
- Recalls: 0 (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)
- 1980: 1
- 1985: 2
- 1986: 1
- 1994: 1
- 2019: 1
- 2023: 2

## Most-cited predicates
- K923792: Quantec Spinal Measuement System (1994), cited by 3

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