510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861582Substantially Equivalent

Injet-100, Fluid Injector

Injet Medical Products, Inc., Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861582 is the FDA 510(k) clearance record for INJET-100, FLUID INJECTOR, a class II device, cleared for Injet Medical Products, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for Injet Medical Products, Inc. As of , FDA records show no recalls naming K861582.

Clearance record

Decision date
Received
(280 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
Injet Medical Products, Inc. 22500 Muirlands Blvd., Lake Forest CA
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