Cleared Special

K162421 - IntelliCartTM System

K162421 is an FDA 510(k) clearance for IntelliCartTM System, manufactured by Dornoch Medical Systems. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Special 510(k) pathway after a 113-day FDA review.

K162421 · Dornoch Medical Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
113d
Days
Class 2
Risk

K162421 is an FDA 510(k) clearance for the IntelliCartTM System. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Dornoch Medical Systems (Riverside, US). The FDA issued a Cleared decision on December 21, 2016 after a review of 113 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 devices

FDA 510(k) Submission Details - K162421

510(k) Number K162421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2016
Decision Date December 21, 2016
Days to Decision 113 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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 43
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K162421.
DV-300 Aspirator
K181398 · Ding Hwa Co., Ltd. · Jul 2018
IntelliCart System
K172481 · Dornoch Medical Systems · Sep 2017
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
K161358 · Surgical Instrument Service and Savings, Inc. · Aug 2017
Stryker Neptune 3 Waste Management System
K153407 · Stryker Corporation · Apr 2016
CLIQ DV-300 ASPIRATOR
K140809 · Ding Hwa Co., Ltd. · Jun 2014
SUCTION PUMP
K140031 · Ding Hwa Co., Ltd. · Apr 2014