# MQS: System, Hemodialysis, Access Recirculation Monitoring

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 136 days (middle half 136–136)
- 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)
- 1996: 3
- 1997: 3
- 1998: 2
- 1999: 2
- 2000: 2
- 2002: 2
- 2004: 1
- 2013: 1
- 2019: 1
- 2023: 1

## Most-cited predicates
- K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2) (1997), cited by 4
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO (1998), cited by 4
- K972470: Crit-Line Monitor (Clmiii) (1997), cited by 3
- K982412: Modification of Crit-Line Monitor Iii (CLM Iii) (1998), cited by 2
- K130579: Physoft Ams (2013), cited by 2
- K953875: Crit-Line Hematocrit Alert (Modification) (1996), cited by 1
- K984194: HP M2376A Device Link System (1999), cited by 1
- K042566: Vasc-Alert (2004), cited by 1

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