Cleared Traditional

K932306 - MICROINFUSOR

K932306 is an FDA 510(k) clearance for MICROINFUSOR, 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 325-day FDA review.

K932306 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
325d
Days
Class 2
Risk

K932306 is an FDA 510(k) clearance for the MICROINFUSOR. 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 1, 1994 after a review of 325 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.

View all Sandhill Scientific, Inc. devices

FDA 510(k) Submission Details - K932306

510(k) Number K932306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date April 01, 1994
Days to Decision 325 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
194d slower than avg
Panel avg: 131d · This submission: 325d
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 K932306.
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · Medtronic-Synectics · Sep 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064 · Laborie Medical Tech Corp. · Jun 1997
SMALL BOWEL ANALYSIS SOFTWARE
K942247 · Sandhill Scientific, Inc. · Apr 1996
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
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · Synectics-Dantec · Aug 1988