Cleared Abbreviated

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 (K051365) - FDA 510(k) Clearance

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

K051365 · K-Jump Health Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
58d
Days
Class 2
Risk

K051365 is an FDA 510(k) clearance for the COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by K-Jump Health Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 58 days - a notably fast clearance 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 K051365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2005
Decision Date July 22, 2005
Days to Decision 58 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
81d faster than avg
Panel avg: 139d · This submission: 58d
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 507
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K051365.
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
K260270 · FindAir Sp. z o.o. · Jun 2026
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