# EXQ: Cystometer, Electrical Recording

- Device class: 2; regulation: 21 CFR 876.1620; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 510(k) review time 2021–2025: median 178 days (middle half 178–178)
- Recalls: 1 (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)
- 1978: 1
- 1981: 1
- 1988: 1
- 1993: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K243052: Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) (2025), cited by 1
- K931574: Advance Model Uds-Adv (1993), cited by 1

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