# K024018: Avant Guardian 101

- Pathway: 510(k) (Traditional)
- Applicant: Avant Medical Corporation
- Decided: Jan 17, 2003 after 44 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: 3 generations back to K864561 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960373: Biojector 2000 Model 1B02000, Bioject, Inc. (1997) Summary page 2.
- K920631: Bioject Jet Injection System, Bioject, Inc. (1994) Summary page 2.
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System, Medi-Ject Corp. (1996) Summary page 2.
- K994384: Clicker, Bioject, Inc. (2000) Summary page 2.
- K945873: Hypex (TM) Jet Injector, Equidyne Systems, Inc. (1995) Summary page 2.

## Indications for use
The Avant GuardianTM101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.

Source page: https://510kreport.com/device/K024018
Methodology: https://510kreport.com/methodology