Cleared Special

K123188 - DORNOCH DUO SUCTION CART WITH DL2800 LI...

K123188 is an FDA 510(k) clearance for DORNOCH DUO SUCTION CART WITH DL2800 LI..., manufactured by Dornoch Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Special 510(k) pathway after a 144-day FDA review.

K123188 · Dornoch Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
144d
Days
Class 2
Risk

K123188 is an FDA 510(k) clearance for the DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION.... Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Dornoch Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on March 4, 2013 after a review of 144 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dornoch Medical Systems, Inc. devices

FDA 510(k) Submission Details - K123188

510(k) Number K123188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2012
Decision Date March 04, 2013
Days to Decision 144 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

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 30
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K123188.
Stryker Neptune 3 Waste Management System
K153407 · Stryker Corporation · Apr 2016
IMPACT MODEL 323 ASPIRATOR
K133196 · Impact Instrumentation, Inc. · Mar 2014
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
K132671 · Stryker Corporation · Dec 2013
PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
K122756 · Penumbra, Inc. · Oct 2012
VACPLUS SUCTION UNIT
K103535 · Apex Medical Corp. · Feb 2011
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · Cardinalhealth · Apr 2008