510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945873Substantially Equivalent

Hypex(tm) Jet Injector

Equidyne Systems, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945873 is the FDA 510(k) clearance record for HYPEX(TM) JET INJECTOR, a class II device, cleared for Equidyne Systems, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 5 510(k) clearances for Equidyne Systems, Inc., from to . As of , FDA records show no recalls naming K945873.

Clearance record

Decision date
Received
(260 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
Equidyne Systems, Inc. 924 Calle Negocio, Suite A, San Clemente CA
510(k) summary
Statement
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