Cleared Traditional

K881781 - CATHETER STRAP

K881781 is the FDA 510(k) clearance for CATHETER STRAP by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K881781 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Aug 1988
Decision
98d
Days
Class 2
Risk

K881781 is an FDA 510(k) clearance for the CATHETER STRAP. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K881781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date August 02, 1988
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 120
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K881781.
CONVEEN INTERMITTENT CATHETERS
K895548 · Coloplast A/S · Feb 1990
KENDALL CURITY IRRIGATION SYRINGE
K892436 · The Kendal Co. · Jul 1989
CATHETERS, MALE, FEMALE
K892691 · Zinnanti Surgical Instruments, Inc. · Jun 1989
SYRINGE PREFILLED WITH WATER
K881363 · I M, Inc. · Jun 1988
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · Cook Urological, Inc. · Mar 1988
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER
K874112 · Van-Tec, Inc. · Feb 1988