Cleared Traditional

K832692 - CURITY CATHETER STRAP

K832692 is an FDA 510(k) clearance for CURITY CATHETER STRAP, manufactured by The Kendal Co.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K832692 · The Kendal Co. · Gastroenterology & Urology device
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Sep 1983
Decision
33d
Days
Class 2
Risk

K832692 is an FDA 510(k) clearance for the CURITY CATHETER STRAP. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 33 days - a notably fast clearance cycle.

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: 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 The Kendal Co. devices

FDA 510(k) Submission Details - K832692

510(k) Number K832692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1983
Decision Date September 12, 1983
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K832692.
CURITY 100% SILICONE COUDE' CATHETER
K833790 · The Kendal Co. · Dec 1983
CATHETER CARE TRAY
K832389 · Inmed Corp. · Sep 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · Electromedics, Inc. · Sep 1983
FOLEY-TEMP
K831567 · Mallinckrodt Critical Care · Aug 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983
URETERAL STONE EXTRACTOR CATHETER
K831244 · American Edwards Laboratories · Jun 1983