Cleared Traditional

FLEXILOG LS 13921 (K961895) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961895 · Oakfield Instruments, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 1996
Decision
172d
Days
Class 2
Risk

K961895 is an FDA 510(k) clearance for the FLEXILOG LS 13921. 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 November 4, 1996 after a review of 172 days - an extended review 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: 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

Submission Details

510(k) Number K961895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date November 04, 1996
Days to Decision 172 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
42d slower than avg
Panel avg: 130d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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