Cleared Traditional

K102626 - VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01

K102626 is an FDA 510(k) clearance for VEGA MEDICAL SUCTION EQUIPMENT, manufactured by Vega Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K102626 · Vega Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
60d
Days
Class 2
Risk

K102626 is an FDA 510(k) clearance for the VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Vega Technologies, Inc. (Taipei, TW). The FDA issued a Cleared decision on November 12, 2010 after a review of 60 days - a notably fast clearance cycle.

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 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.

FDA 510(k) Submission Details - K102626

510(k) Number K102626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date November 12, 2010
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCX Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K102626.
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
K120065 · Plaxtron Industrial (M) Sdn. Bhd. · Apr 2012
EMG SUCTION UNIT
K112421 · Emg Technology Co., Ltd. · Sep 2011
VACPLUS SUCTION UNIT
K103535 · Apex Medical Corp. · Feb 2011
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
K090759 · Biodrain Medical, Inc. · Apr 2009
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
K082762 · Aardvark Medical · Nov 2008
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · Cardinalhealth · Apr 2008