# K013256: BI-3M Needle-Free Injector System

- Pathway: 510(k) (Traditional)
- Applicant: Felton International, Inc.
- Decided: Dec 7, 2001 after 67 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: 1 generation back to K945543 (1994). 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)
- K945543: Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone, Intersect Medical Products, Inc. (1994) Summary page 1.
- (no number) Ped-O-Jet: named in the summary without a submission number

## Most influential descendants
- K041280: Human Subcutaneous Injector, Model Hsi 500 (2004), 0 descendants of its own

## 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/K013256
Methodology: https://510kreport.com/methodology