# K090959: Lectrajet Needle-Free Injection System, Model: M3 RA

- Pathway: 510(k) (Traditional)
- Applicant: D'Antonio Consultants International, Inc. (Dci)
- Decided: Dec 24, 2009 after 262 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 1.
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System, Medi-Ject Corp. (1996) Summary page 1.

## Indications for use
The LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SO) or intramuscular (IM) injections of vaccines and other injectable medications. The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.

Source page: https://510kreport.com/device/K090959
Methodology: https://510kreport.com/methodology