# KZE: Injector, Fluid, Non-Electrically Powered

- Device class: 2; regulation: 21 CFR 880.5430; FDA's rule: 510(k) required
- FDA decisions: 53
- Recalls: 1 (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)
- 2000: 1
- 2001: 4
- 2002: 3
- 2003: 1
- 2004: 3
- 2005: 2
- 2006: 1
- 2009: 4
- 2011: 2
- 2012: 1

## Most-cited predicates
- K960373: Biojector 2000 Model 1B02000 (1997), cited by 7
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System (1996), cited by 4
- K920631: Bioject Jet Injection System (1994), cited by 4
- K945873: Hypex (TM) Jet Injector (1995), cited by 3
- K994384: Clicker (2000), cited by 3
- K081532: Pharmajet Needle-Free Injection System (2009), cited by 2
- K003741: Jet Syringe Model-100500 (2001), cited by 2
- K864561: Derata Medi-Jector IV (1987), cited by 2
- K960285: Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific (1996), cited by 2
- K883847: Derata Medi-Jector V (1988), cited by 2

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