Cleared Traditional

K855060 - CURITY PERCUTANEOUS CATHETER INSERTION TRAY

K855060 is an FDA 510(k) clearance for CURITY PERCUTANEOUS CATHETER INSERTION TRAY, manufactured by The Kendal Co.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K855060 · The Kendal Co. · Cardiovascular device
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Apr 1986
Decision
119d
Days
Class 2
Risk

K855060 is an FDA 510(k) clearance for the CURITY PERCUTANEOUS CATHETER INSERTION TRAY. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on April 16, 1986 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all The Kendal Co. devices

FDA 510(k) Submission Details - K855060

510(k) Number K855060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date April 16, 1986
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 434
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K855060.
TERUMO RADIFOCUS INTRODUCER KIT
K863139 · Terumo Medical Corp. · Oct 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986
CATHETER INTRODUCER
K860958 · Target Therapeutics · Apr 1986
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · The Kendal Co. · Apr 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985