# FLN: Monitor, Electric For Gravity Flow Infusion Systems

- Device class: 2; regulation: 21 CFR 880.2420; FDA's rule: 510(k) required
- FDA decisions: 39
- 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)
- 1993: 1
- 1997: 2
- 2001: 1
- 2002: 1
- 2003: 1
- 2006: 2
- 2008: 1
- 2014: 1
- 2015: 1
- 2018: 1

## Most-cited predicates
- K030136: Drip Alert (2003), cited by 2
- K022248: Stryker L3 Hydrolert (2002), cited by 1
- K844556: KHM 2000 Drip Watcher (1985), cited by 1
- K150687: DripAssist (2015), cited by 1
- K903193: Smith & Nephew Dyonics Levelert System (1990), cited by 1

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