Cleared Abbreviated

K121520 - ULTRASONIC NEBULIZER (MESH TYPE) (FDA 510(k) Clearance)

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

K121520 · K-Jump Health Co., Ltd. · Anesthesiology device
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.

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
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 225d · 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 10
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K121520.
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
Mesh Nebulizer (H6)
K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
Portable mesh nebulizer (JM821)
K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
Compressor Nebulizer (NB-1100)
K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025