# LZH: Pump, Infusion, Enteral

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 201 days (middle half 146–244)
- Recalls: 15 (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)
- 2004: 2
- 2006: 1
- 2012: 1
- 2014: 2
- 2015: 1
- 2016: 1
- 2020: 1
- 2022: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K040196: Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets (2004), cited by 4
- K954735: Enteralite (1996), cited by 3
- K945964: Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets (1995), cited by 3
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), cited by 2
- K031199: Enteralite Infinity Enteral Feeding Pump (2003), cited by 2
- K940555: Sandoz Nutrition Compat Enteral Feed Pump W/Hydration (1995), cited by 2
- K143263: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (2015), cited by 2
- K981541: Clearstar Enteral Nutrition Pump (1998), cited by 1
- K011587: Sentinel Enteral Feeding Pump, LH2001 Enteral Feeding Pump (2001), cited by 1
- K940556: Sandoz Nutrition Compat (R) Enteral Feeding Pump (1994), cited by 1

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