Cleared Abbreviated

K042349 - EMG MODEL SUA01 SUCTION UNIT (FDA 510(k) Clearance)

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

K042349 · Emg Technology Co., Ltd. · General & Plastic Surgery device
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Dec 2004
Decision
108d
Days
Class 2
Risk

K042349 is an FDA 510(k) clearance for the EMG MODEL SUA01 SUCTION UNIT. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Emg Technology Co., Ltd. (Baltimore, US). The FDA issued a Cleared decision on December 16, 2004 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Emg Technology Co., Ltd. devices

Submission Details

510(k) Number K042349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date December 16, 2004
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 114d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

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