Cleared Traditional

K103409 - ALLERGEAZE R CLEAR

K103409 is an FDA 510(k) clearance for ALLERGEAZE R CLEAR, manufactured by Smartpractice. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K103409 · Smartpractice · General Hospital
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Mar 2011
Decision
113d
Days
Class 1
Risk

K103409 is an FDA 510(k) clearance for the ALLERGEAZE R CLEAR. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on March 15, 2011 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K103409

510(k) Number K103409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date March 15, 2011
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

KXF Device Classification - Class 1, General Controls

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KXF Applicator, Absorbent Tipped, Non-sterile

All 10
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K103409.
EAR APPLICATOR, CATALOG NO. 2229
K870762 · Treace Medical, Inc. · Mar 1987
COTTON TIPPED APPLICATORS, SINGLE
K843720 · Abco Dealers, Inc. · Oct 1984
SUBCLAVIAN CATHETER INSERTION TRAY
K802580 · American Pharmaseal Div. Ahsc · Nov 1980
EYE APPLICATORS CAT.#980-983
K802016 · Pollak (Intl.), Ltd. · Sep 1980
PREP SET CAT.#908
K802020 · Pollak (Intl.), Ltd. · Sep 1980
DEXIDE DISPOSABLE PREP STICK
K791168 · Dexide, Inc. · Jul 1979