Cleared Special

K013154 - MARK II/MARK III MANOMETRIC PERFUSION PUMP

K013154 is an FDA 510(k) clearance for MARK II/MARK III MANOMETRIC PERFUSION PUMP, manufactured by Dentsleeve Pty., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Special 510(k) pathway after a 29-day FDA review.

K013154 · Dentsleeve Pty., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
29d
Days
Class 2
Risk

K013154 is an FDA 510(k) clearance for the MARK II/MARK III MANOMETRIC PERFUSION PUMP. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Dentsleeve Pty., Ltd. (Golden, US). The FDA issued a Cleared decision on October 19, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology 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 Dentsleeve Pty., Ltd. devices

FDA 510(k) Submission Details - K013154

510(k) Number K013154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date October 19, 2001
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FFX System, Gastrointestinal Motility (electrical)

All 19
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K013154.
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