# KZH: Introducer, Syringe Needle

- Device class: 2; regulation: 21 CFR 880.6920; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 209 days (middle half 132–287)
- Recalls: 8 (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)
- 2006: 3
- 2007: 1
- 2008: 2
- 2012: 2
- 2013: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K013362: Autoject 2 (2001), cited by 6
- K945660: Autoject 2 (1995), cited by 5
- K992300: Quick-Serter, Model 395 (1999), cited by 3
- K872233: Inject-Ease (1987), cited by 2
- K010377: Mimimed Sil-Serter Infusion Set Insertion System, Model 385 (2001), cited by 2
- K000482: Modification to Autoject Mini (2000), cited by 2
- K974678: B-D Auto-Injector (1998), cited by 2
- K124026: Lobster Auto-Injector (2013), cited by 2
- K032425: Invisiject Resusable Auto-Injector (2003), cited by 2
- K033696: Personal Injector (2005), cited by 2

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