510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K024018Substantially Equivalent

Avant Guardian 101

Avant Medical Corporation, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024018 is the FDA 510(k) clearance record for AVANT GUARDIAN 101, a class II device, cleared for Avant Medical Corporation on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for Avant Medical Corporation. As of , FDA records show no recalls naming K024018.

Clearance record

Decision date
Received
(44 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
Avant Medical Corporation 3914 Kendall St., San Diego CA
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