# LQK: Home Uterine Activity Monitor

- Device class: 2; regulation: 21 CFR 884.2730; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 86 days (middle half 57–115)
- 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)
- 1995: 2
- 2002: 1
- 2015: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K143114: Sense4Baby System Model B+ (MSA) (2015), cited by 3
- K020390: Modification to Fetal Assist (2002), cited by 1
- K210025: INVU by Nuvo (2021), cited by 1

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