Cleared Traditional

K832869 - MOTILITY MEASUREMENT SYS MMS-100

K832869 is an FDA 510(k) clearance for MOTILITY MEASUREMENT SYS MMS-100, manufactured by Narco Bio-Systems. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K832869 · Narco Bio-Systems · Gastroenterology & Urology device
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Oct 1983
Decision
68d
Days
Class 2
Risk

K832869 is an FDA 510(k) clearance for the MOTILITY MEASUREMENT SYS MMS-100. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Narco Bio-Systems (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Narco Bio-Systems devices

FDA 510(k) Submission Details - K832869

510(k) Number K832869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1983
Decision Date October 31, 1983
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 131d · This submission: 68d
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 51
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K832869.
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · Wilson-Cook Medical, Inc. · Jul 1990
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · Synectics-Dantec · Aug 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · Mentor Corp. · Feb 1988
SYN-02 PN AMPLIFIER
K830421 · Biosearch Medical Products, Inc. · Apr 1983
ESOPHAGEAL MOTILITY APPARATUS
K812103 · Honeywell, Inc. · Aug 1981
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · Honeywell, Inc. · Jun 1978