Cleared Traditional

K854137 - ARROW BRACHIAL CENTRAL VENOUS CATH-KIT ...

K854137 is an FDA 510(k) clearance for ARROW BRACHIAL CENTRAL VENOUS CATH-KIT ..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K854137 · Arrow Intl., Inc. · Cardiovascular device
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Dec 1985
Decision
54d
Days
Class 2
Risk

K854137 is an FDA 510(k) clearance for the ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K854137

510(k) Number K854137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1985
Decision Date December 03, 1985
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K854137.
CUP MONITORING KIT CVPK-14
K854984 · Medical Components, Inc. · Mar 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · Cook, Inc. · Feb 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · American Pharmaseal Div. Ahsc · Jan 1986
GUIDING CATHETER
K853998 · Target Therapeutics · Nov 1985
INFUSION CATHETER
K853997 · Target Therapeutics · Nov 1985
INFUSION CATHETER W/SIDE HOLES
K854000 · Target Therapeutics · Nov 1985