Cleared Abbreviated

EMG MODEL SUA01 SUCTION UNIT (K042349) - 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
7d faster than avg
Panel avg: 115d · 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

All 13
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K042349.
TWBM Pump
K180115 · Taiwan Biomaterial Co., Ltd. · Jul 2018
DV-300 Aspirator
K181398 · Ding Hwa Co., Ltd. · Jul 2018
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc. · Oct 2012
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
K914694 · Depuy, Inc. · Jan 1992