Cleared Special

K262621 - Rapid Barostat Bag (RBB) Pump and Catheter System

K262621 is an FDA 510(k) clearance for Rapid Barostat Bag (RBB) Pump and Cathe..., manufactured by Mui Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Special 510(k) pathway after a 64-day FDA review.

K262621 · Mui Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Sep 2026
Decision
64d
Days
Class 2
Risk

K262621 is an FDA 510(k) clearance for the Rapid Barostat Bag (RBB) Pump and Catheter System. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Mui Scientific, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 30, 2026 after a review of 64 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 Mui Scientific, Inc. devices

FDA 510(k) Submission Details - K262621

510(k) Number K262621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2026
Decision Date September 30, 2026
Days to Decision 64 days
Submission Type Special
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
67d faster than avg
Panel avg: 131d · This submission: 64d
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 60
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