Cleared Special

K052338 - SOLAR GI

K052338 is an FDA 510(k) clearance for SOLAR GI, manufactured by Medical Measurement Systems B.V.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Special 510(k) pathway after a 111-day FDA review.

K052338 · Medical Measurement Systems B.V. · Gastroenterology & Urology device
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Dec 2005
Decision
111d
Days
Class 2
Risk

K052338 is an FDA 510(k) clearance for the SOLAR GI. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Medical Measurement Systems B.V. (Enschede Overijssel, NL). The FDA issued a Cleared decision on December 15, 2005 after a review of 111 days - within the typical 510(k) review window.

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. 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 Medical Measurement Systems B.V. devices

FDA 510(k) Submission Details - K052338

510(k) Number K052338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date December 15, 2005
Days to Decision 111 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 131d · This submission: 111d
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 52
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K052338.
MODIFICATION TO SOLAR GI
K071094 · Medical Measurement Systems B.V. · Aug 2007
UNITIP HIGH RESOLUTION CATHETER
K062222 · Unisensor AG · Mar 2007
OHMEGA
K060166 · Medical Measurement Systems B.V. · Apr 2006
INSIGHT, MODEL S980000
K012232 · Sandhill Scientific, Inc. · Jun 2002
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · Sandhill Scientific, Inc. · Jun 2001
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
K992713 · Medtronic Functional Diagnostics A/S · Nov 1999