Cleared Traditional

K011471 - BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

K011471 is an FDA 510(k) clearance for BILITEC 2000, 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 543-day FDA review.

K011471 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
543d
Days
Class 2
Risk

K011471 is an FDA 510(k) clearance for the BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER .... 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 November 8, 2002 after a review of 543 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 Medtronic Functional Diagnostics A/S devices

FDA 510(k) Submission Details - K011471

510(k) Number K011471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date November 08, 2002
Days to Decision 543 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
412d slower than avg
Panel avg: 131d · This submission: 543d
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 K011471.
UNITIP HIGH RESOLUTION CATHETER
K062222 · Unisensor AG · Mar 2007
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