Cleared Traditional

K990441 - INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300

K990441 is an FDA 510(k) clearance for INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, 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 90-day FDA review.

K990441 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
90d
Days
Class 2
Risk

K990441 is an FDA 510(k) clearance for the INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300. 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 May 12, 1999 after a review of 90 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K990441

510(k) Number K990441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date May 12, 1999
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 K990441.
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · Medtronic Functional Diagnostics A/S · Jul 1999
DISTENDER SERIES II BAROSTAT
K991288 · G & J Electronics, Inc. · Jun 1999
GASTRIC AND RECTAL CATHETERS
K973844 · G & J Electronics, Inc. · Jun 1999
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
K981733 · Medtronic Functional Diagnostics A/S · Feb 1999
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
K984444 · Sandhill Scientific, Inc. · Jan 1999
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980 · Konigsberg Instruments, Inc. · Jun 1998