# K962999: Safety Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Integritech, Inc.
- Decided: Jan 22, 1997 after 173 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851903 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851903: Astra Lightweight Stainless Steel Self Aspir/Syrin, Astra Pharmaceutical Products, Inc. (1985)

## Most influential descendants
- K023722: Safetywand Disposable Handpiece (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K962999
Methodology: https://510kreport.com/methodology