Cleared Traditional

K011472 - POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

K011472 is an FDA 510(k) clearance for POLYGRAM 98 ANORECTAL FUNCTION TESTING ..., manufactured by Medtronic Functional Diagnostics A/S. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011472 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
88d
Days
Class 2
Risk

K011472 is an FDA 510(k) clearance for the POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MA.... Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on August 10, 2001 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Functional Diagnostics A/S devices

FDA 510(k) Submission Details - K011472

510(k) Number K011472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date August 10, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
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 53
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K011472.
OHMEGA
K060166 · Medical Measurement Systems B.V. · Apr 2006
SOLAR GI
K052338 · Medical Measurement Systems B.V. · Dec 2005
INSIGHT, MODEL S980000
K012232 · Sandhill Scientific, Inc. · Jun 2002
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K002427 · Sandhill Scientific, Inc. · Jun 2001
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
K992713 · Medtronic Functional Diagnostics A/S · Nov 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · Medtronic Functional Diagnostics A/S · Jul 1999