Cleared Traditional

K120524 - SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM

K120524 is an FDA 510(k) clearance for SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM, manufactured by Mui Scientific. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K120524 · Mui Scientific · Gastroenterology & Urology device
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Jun 2012
Decision
120d
Days
Class 2
Risk

K120524 is an FDA 510(k) clearance for the SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Mui Scientific (Mississauga, CA). The FDA issued a Cleared decision on June 21, 2012 after a review of 120 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mui Scientific devices

FDA 510(k) Submission Details - K120524

510(k) Number K120524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2012
Decision Date June 21, 2012
Days to Decision 120 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 131d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K120524.
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K122294 · Mui Scientific · Nov 2012
BAROSTAT SOFTWARE OPTION
K120997 · Crospon, Ltd. · Aug 2012
SOLAR GI
K121014 · Medical Measurement Systems B.V. · Aug 2012
ENDO FLIP
K102214 · Crospon, Ltd. · Dec 2010
PHTIP DISPOSABLE ISFET CATHETER
K102801 · E-Cath Co., Ltd. · Oct 2010
ENDOFLIP
K092850 · Crospon, Ltd. · Dec 2009