Cleared Abbreviated

K121520 - ULTRASONIC NEBULIZER (MESH TYPE)

K121520 is the FDA 510(k) clearance for ULTRASONIC NEBULIZER (MESH TYPE) 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 297-day FDA review.

K121520 · K-Jump Health Co., Ltd. · Anesthesiology device
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Mar 2013
Decision
297d
Days
Class 2
Risk

K121520 is an FDA 510(k) clearance for the ULTRASONIC NEBULIZER (MESH TYPE). Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (New Taipei, TW). The FDA issued a Cleared decision on March 15, 2013 after a review of 297 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 K121520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2012
Decision Date March 15, 2013
Days to Decision 297 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
157d slower than avg
Panel avg: 140d · This submission: 297d
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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K121520.
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K121969 · Taidoc Technology Corporation · Feb 2013
COMP A-I-R
K110860 · Omron Healthcare, Inc. · Sep 2011
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · Instrumentation Industries, Inc. · Jul 2010