Cleared Abbreviated

SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (K002427) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002427 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
318d
Days
Class 2
Risk

K002427 is an FDA 510(k) clearance for the SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sandhill Scientific, Inc. devices

Submission Details

510(k) Number K002427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2000
Decision Date June 22, 2001
Days to Decision 318 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 130d · This submission: 318d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 68
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