# MSQ: Test, Urea (Breath Or Blood)

- Device class: 1; regulation: 21 CFR 866.3110; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 121 days (middle half 75–147)
- 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)
- 2000: 1
- 2001: 1
- 2002: 1
- 2004: 1
- 2010: 2
- 2013: 1
- 2016: 1
- 2018: 2
- 2020: 1
- 2022: 3

## Most-cited predicates
- K130524: Breathid HP System (2013), cited by 2
- K173777: BreathID Hp Lab System (2018), cited by 2
- K093834: Crit-Line Anemia Management Software (2010), cited by 1
- K220494: BreathID Hp Lab System, BreathID Smart System (2022), cited by 1
- K972352: The Meretek Ubt Breath Test for H.Pylori (1997), cited by 1
- K162150: BreathID Hp Lab System (2016), cited by 1
- K011668: Validation of the Breathid System, for the Detection of Helicbactor Pylori (2001), cited by 1
- K193610: BreathID Smart System (2020), cited by 1
- K173772: BreathID Hp System (2018), cited by 1

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