Cleared Traditional

K002153 - ULTRASONIC NEBULIZER, MODEL NE-520

K002153 is an FDA 510(k) clearance for ULTRASONIC NEBULIZER, manufactured by Medisana USA, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K002153 · Medisana USA, Inc. · Anesthesiology device
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Mar 2001
Decision
239d
Days
Class 2
Risk

K002153 is an FDA 510(k) clearance for the ULTRASONIC NEBULIZER, MODEL NE-520. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medisana USA, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on March 13, 2001 after a review of 239 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002153

510(k) Number K002153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date March 13, 2001
Days to Decision 239 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 140d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K002153.
VEGA ULTRASONIC NEBULIZER
K002831 · Vega Technologies, Inc. · May 2001
CT SPACER
K010680 · Clinical Technologies, Inc. · May 2001
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K003344 · Medical Depot, Inc. · Mar 2001
LITEAIRE
K993101 · Thayer Medical Corp. · Oct 2000
AERONEB PORTABLE NEBULIZER
K003022 · Aerogen, Inc. · Oct 2000
AERONEB II, MODEL APN 200
K992831 · Aerogen, Inc. · Aug 2000
K002153 · ULTRASONIC NEBULIZER, MODEL NE-520
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