510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090959Substantially Equivalent

Lectrajet Needle-Free Injection System, Model: M3 Ra

D'Antonio Consultants International, Inc. (Dci), East Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090959 is the FDA 510(k) clearance record for LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA, a class II device, cleared for D'Antonio Consultants International, Inc. (Dci) on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for D'Antonio Consultants International, Inc. (Dci). As of , FDA records show no recalls naming K090959.

Clearance record

Decision date
Received
(262 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
D'Antonio Consultants International, Inc. (Dci) 6308 Fly Rd., East Syracuse NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZE

Trailing 12 months

FDA records hold no clearances under product code KZE in the trailing twelve months.

FDA records show no clearances under product code KZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260