# QMS: Adjunctive Open Loop Fluid Therapy Recommender

- Device class: 2; regulation: 21 CFR 870.5600; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 228 days (middle half 228–228)
- 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)
- 2020: 1
- 2024: 1

## Most-cited predicates
- DEN190029: Acumen Assisted Fluid Management (AFM) Software Feature (2020), cited by 1

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