Cleared Traditional

K983665 - MANOMETRIC ASSEMBLIES

K983665 is an FDA 510(k) clearance for MANOMETRIC ASSEMBLIES, manufactured by Dentsleeve Pty., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K983665 · Dentsleeve Pty., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
210d
Days
Class 2
Risk

K983665 is an FDA 510(k) clearance for the MANOMETRIC ASSEMBLIES. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Dentsleeve Pty., Ltd. (Parkside South Australia, AU). The FDA issued a Cleared decision on May 17, 1999 after a review of 210 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 Dentsleeve Pty., Ltd. devices

FDA 510(k) Submission Details - K983665

510(k) Number K983665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date May 17, 1999
Days to Decision 210 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
79d slower than avg
Panel avg: 131d · This submission: 210d
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 22
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K983665.
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · Medspira, LLC · Mar 2012
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
K062362 · Sarmed Srl · Apr 2007
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138 · Medtronic Vascular · Oct 2003
FLEXILOG LS
K964804 · Oakfield Instruments, Ltd. · Aug 1997
FLEXILOG 3000
K964589 · Oakfield Instruments, Ltd. · Mar 1997
FLEXILOG LS 13921
K961895 · Oakfield Instruments, Ltd. · Nov 1996