# LZG: Pump, Infusion, Insulin

- Device class: 2; regulation: 21 CFR 880.5725; FDA's rule: 510(k) required
- FDA decisions: 85
- 510(k) review time 2021–2025: median 171 days (middle half 84–229)
- Recalls: 106 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2016: 4
- 2017: 1
- 2018: 1
- 2019: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2026: 2

## Most-cited predicates
- K042792: Ixl-II Diabetes Management System (2005), cited by 6
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump (1997), cited by 5
- K990801: Minimed 508 Insulin Pump (1999), cited by 4
- K122953: Omnipod Insulin Managment System (2012), cited by 4
- K042873: Animas Model IR1250 Insulin Infusion Pump (2004), cited by 3
- K111353: Accu-Check Combo System (2012), cited by 3
- K994186: Disetronic D-Tron Insulin Infusion Pump (1999), cited by 3
- K031373: Ixl Diabetes Management System (2003), cited by 3
- K141758: T:Slim Insulin Delivery System (2014), cited by 3
- K001604: Dana Diabecare (2000), cited by 3

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