Cleared Traditional

K911242 - KENDALL PEDIATRIC ULTRAMER POLYURETHANE...

K911242 is an FDA 510(k) clearance for KENDALL PEDIATRIC ULTRAMER POLYURETHANE..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K911242 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
35d
Days
Class 2
Risk

K911242 is an FDA 510(k) clearance for the KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 25, 1991 after a review of 35 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K911242

510(k) Number K911242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1991
Decision Date April 25, 1991
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 139
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K911242.
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992
KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.
K921054 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1992
NAUDE URETHRAL STENT
K912851 · Cook Urological, Inc. · Jan 1992
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990
DISPOSABLE URODYNAMIC CATHETER SET
K896784 · Life-Tech Intl., Inc. · Feb 1990