Cleared Traditional

K921055 - KENDALL CURITY KIDS PEDIATRIC DRAINAGE ...

K921055 is an FDA 510(k) clearance for KENDALL CURITY KIDS PEDIATRIC DRAINAGE ..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
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May 1992
Decision
67d
Days
Class 2
Risk

K921055 is an FDA 510(k) clearance for the KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on May 11, 1992 after a review of 67 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 - K921055

510(k) Number K921055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date May 11, 1992
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 25
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K921055.
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
HYDROPHILIC COATED GUIDEWIRE
K926344 · Surgitek · Mar 1993
GUIDEWIRE
K921200 · Lake Region Mfg., Inc. · Sep 1992
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990