Cleared Traditional

K991288 - DISTENDER SERIES II BAROSTAT

K991288 is an FDA 510(k) clearance for DISTENDER SERIES II BAROSTAT, manufactured by G & J Electronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K991288 · G & J Electronics, Inc. · Gastroenterology & Urology device
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Jun 1999
Decision
55d
Days
Class 2
Risk

K991288 is an FDA 510(k) clearance for the DISTENDER SERIES II BAROSTAT. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by G & J Electronics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on June 8, 1999 after a review of 55 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 G & J Electronics, Inc. devices

FDA 510(k) Submission Details - K991288

510(k) Number K991288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1999
Decision Date June 08, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
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 19
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K991288.
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