Cleared Abbreviated

K083256 - ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K083256 · K-Jump Health Co., Ltd. · Anesthesiology device
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.

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
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 225d · 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 10
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K083256.
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HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025