510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041239Substantially Equivalent

Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000

Genesis Medical Technology, Inc., Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041239 is the FDA 510(k) clearance record for GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000, a class II device, cleared for Genesis Medical Technology, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for Genesis Medical Technology, Inc. As of , FDA records show no recalls naming K041239.

Clearance record

Decision date
Received
(181 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
Genesis Medical Technology, Inc. 1555 E. Flamingo Rd., Las Vegas NV
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