Cleared Abbreviated

K002427 - SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026

K002427 is an FDA 510(k) clearance for SANDHILL UNITIP CATHETER PRESSURE SENSOR, manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Abbreviated 510(k) pathway after a 318-day FDA review.

K002427 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K002427

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 131d · This submission: 318d
Pathway characteristics
Standards-based clearance path.

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 69
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K002427.
MARK II/MARK III MANOMETRIC PERFUSION PUMP
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K003580 · Unisensor AG · Jul 2001
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K004040 · Red-Tech, Inc. · Mar 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130 · Medtronic Functional Diagnostics A/S · Feb 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
K000386 · Medtronic Functional Diagnostics A/S · May 2000
K002427 · SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
Download PDF FDA Summary Sandhill Scientific, …