Cleared Abbreviated

K083256 - ULTRASONIC NEBULIZER SYSTEM

K083256 is the FDA 510(k) clearance for ULTRASONIC NEBULIZER SYSTEM by K-Jump Health Co., Ltd.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Abbreviated 510(k) pathway after a 234-day FDA review.

K083256 · K-Jump Health Co., Ltd. · Anesthesiology device
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Jun 2009
Decision
234d
Days
Class 2
Risk

K083256 is an FDA 510(k) clearance for the ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Taipei Hsien, TW). The FDA issued a Cleared decision on June 26, 2009 after a review of 234 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all K-Jump Health Co., Ltd. devices

Submission Details

510(k) Number K083256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date June 26, 2009
Days to Decision 234 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 140d · This submission: 234d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 133
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