Cleared Special

K172481 - IntelliCart System

K172481 is an FDA 510(k) clearance for IntelliCart 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 29-day FDA review.

K172481 · Dornoch Medical Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
29d
Days
Class 2
Risk

K172481 is an FDA 510(k) clearance for the IntelliCart 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 September 14, 2017 after a review of 29 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. 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. Low regulatory complexity profile. 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 - K172481

510(k) Number K172481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2017
Decision Date September 14, 2017
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K172481.
ZOOM Aspiration Pump
K190105 · Taiwan Biomaterial Co., Ltd. · Feb 2019
TWBM Pump
K180115 · Taiwan Biomaterial Co., Ltd. · Jul 2018
DV-300 Aspirator
K181398 · Ding Hwa Co., Ltd. · Jul 2018
Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
K161358 · Surgical Instrument Service and Savings, Inc. · Aug 2017
IntelliCartTM System
K162421 · Dornoch Medical Systems · Dec 2016
Stryker Neptune 3 Waste Management System
K153407 · Stryker Corporation · Apr 2016