Cleared Traditional

K942247 - SMALL BOWEL ANALYSIS SOFTWARE

K942247 is an FDA 510(k) clearance for SMALL BOWEL ANALYSIS SOFTWARE, 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 701-day FDA review.

K942247 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
701d
Days
Class 2
Risk

K942247 is an FDA 510(k) clearance for the SMALL BOWEL ANALYSIS SOFTWARE. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on April 9, 1996 after a review of 701 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Sandhill Scientific, Inc. devices

FDA 510(k) Submission Details - K942247

510(k) Number K942247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date April 09, 1996
Days to Decision 701 days
Submission Type Traditional
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
570d slower than avg
Panel avg: 131d · This submission: 701d
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 41
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K942247.
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K980946 · Dentsleeve Pty., Ltd. · Jun 1998
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · Medtronic-Synectics · Sep 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064 · Laborie Medical Tech Corp. · Jun 1997
MICROINFUSOR
K932306 · Sandhill Scientific, Inc. · Apr 1994
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
K920664 · Diagnostic Ultrasound Corp. · Dec 1993
WILSON-COOK BILIARY MOTILITY CATHETER
K900058 · Wilson-Cook Medical, Inc. · Jul 1990