Cleared Traditional

K972439 - ANORECTAL MANOMETRY ANALYSIS MODULE

K972439 is an FDA 510(k) clearance for ANORECTAL MANOMETRY ANALYSIS MODULE, manufactured by Medtronic-Synectics. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972439 · Medtronic-Synectics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
85d
Days
Class 2
Risk

K972439 is an FDA 510(k) clearance for the ANORECTAL MANOMETRY ANALYSIS MODULE. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Medtronic-Synectics (Stockholm, SE). The FDA issued a Cleared decision on September 23, 1997 after a review of 85 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-Synectics devices

FDA 510(k) Submission Details - K972439

510(k) Number K972439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date September 23, 1997
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
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 52
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K972439.
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
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
K980946 · Dentsleeve Pty., Ltd. · Jun 1998
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
MICROINFUSOR
K932306 · Sandhill Scientific, Inc. · Apr 1994