Cleared Traditional

K964589 - FLEXILOG 3000

K964589 is an FDA 510(k) clearance for FLEXILOG 3000, manufactured by Oakfield Instruments, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K964589 · Oakfield Instruments, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
109d
Days
Class 2
Risk

K964589 is an FDA 510(k) clearance for the FLEXILOG 3000. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on March 4, 1997 after a review of 109 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 Oakfield Instruments, Ltd. devices

FDA 510(k) Submission Details - K964589

510(k) Number K964589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date March 04, 1997
Days to Decision 109 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
22d faster than avg
Panel avg: 131d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLA Device Classification - Class 2, Special Controls

Product Code KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
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 - KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

All 19
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K964589.
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138 · Medtronic Vascular · Oct 2003
MANOMETRIC ASSEMBLIES
K983665 · Dentsleeve Pty., Ltd. · May 1999
FLEXILOG LS
K964804 · Oakfield Instruments, Ltd. · Aug 1997
FLEXILOG LS 13921
K961895 · Oakfield Instruments, Ltd. · Nov 1996
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K961070 · Synectics Medical, Inc. · Jun 1996
BIOVIEW MODEL S960000
K961056 · Sandhill Scientific, Inc. · Jun 1996