Cleared Traditional

K012232 - INSIGHT, MODEL S980000

K012232 is an FDA 510(k) clearance for INSIGHT, manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K012232 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
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Jun 2002
Decision
326d
Days
Class 2
Risk

K012232 is an FDA 510(k) clearance for the INSIGHT, MODEL S980000. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Boulder, US). The FDA issued a Cleared decision on June 7, 2002 after a review of 326 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012232

510(k) Number K012232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date June 07, 2002
Days to Decision 326 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 131d · This submission: 326d
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 69
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K012232.
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BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
K011471 · Medtronic Functional Diagnostics A/S · Nov 2002
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · Dentsleeve Pty., Ltd. · Oct 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
K011472 · Medtronic Functional Diagnostics A/S · Aug 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580 · Unisensor AG · Jul 2001
K012232 · INSIGHT, MODEL S980000
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