Cleared Traditional

K024018 - AVANT GUARDIAN 101

K024018 is an FDA 510(k) clearance for AVANT GUARDIAN 101, manufactured by Avant Medical Corporation. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K024018 · Avant Medical Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
44d
Days
Class 2
Risk

K024018 is an FDA 510(k) clearance for the AVANT GUARDIAN 101. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Avant Medical Corporation (San Diego, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avant Medical Corporation devices

FDA 510(k) Submission Details - K024018

510(k) Number K024018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date January 17, 2003
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZE Injector, Fluid, Non-electrically Powered

All 12
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K024018.
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K111517 · Pharmajet, Inc. · Jul 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · Pharmajet, Inc. · Mar 2011
CLICKER
K994384 · Bioject, Inc. · Jun 2000
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K991294 · Medi-Ject Corp. · Apr 1999
J-TIP NEEDLESS INJECTOR
K980082 · National Medical Products, Inc. · Mar 1998