Cleared Traditional

K881310 - DENT SLEEVE MANOMETRIC CATHETER

K881310 is an FDA 510(k) clearance for DENT SLEEVE MANOMETRIC CATHETER, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K881310 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
53d
Days
Class 2
Risk

K881310 is an FDA 510(k) clearance for the DENT SLEEVE MANOMETRIC CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on May 20, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K881310

510(k) Number K881310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date May 20, 1988
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 131d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K881310.
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K882867 · Corpak Co. · Sep 1988
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · Sandoz Nutrition · Sep 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · Medical Innovations Corp. · Aug 1988
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
K874154 · Electro-Catheter Corp. · Apr 1988
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · Medical Innovations Corp. · Apr 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · Medsurg Industries, Inc. · Apr 1988