# K041280: Human Subcutaneous Injector, Model Hsi 500

- Pathway: 510(k) (Special)
- Applicant: Felton International, Inc.
- Decided: Jun 24, 2004 after 42 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945543 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013256: BI-3M Needle-Free Injector System, Felton International, Inc. (2001) Summary page 1.
- (no number) Ped-O-Jet: named in the summary without a submission number

## Indications for use
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only.

Source page: https://510kreport.com/device/K041280
Methodology: https://510kreport.com/methodology