Cleared Traditional

K052811 - HSINER JET NEBULIZER

K052811 is an FDA 510(k) clearance for HSINER JET NEBULIZER, manufactured by Hsiner Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K052811 · Hsiner Co., Ltd. · Anesthesiology device
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Dec 2005
Decision
78d
Days
Class 2
Risk

K052811 is an FDA 510(k) clearance for the HSINER JET NEBULIZER, MODEL HS-31100. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on December 21, 2005 after a review of 78 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hsiner Co., Ltd. devices

FDA 510(k) Submission Details - K052811

510(k) Number K052811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date December 21, 2005
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K052811.
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
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K051260 · Allied Healthcare Products, Inc. · Sep 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · K-Jump Health Co., Ltd. · Jul 2005
APEX MEDICAL MININEB & MINIPLUS
K050104 · Apex Medical Corp. · Feb 2005