Cleared Traditional

K842316 - CRITIKON TRIPLE-LUMEN CENTRAL VENOUS

K842316 is an FDA 510(k) clearance for CRITIKON TRIPLE-LUMEN CENTRAL VENOUS, manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K842316 · Critikon Company, LLC · Cardiovascular device
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Jul 1984
Decision
38d
Days
Class 2
Risk

K842316 is an FDA 510(k) clearance for the CRITIKON TRIPLE-LUMEN CENTRAL VENOUS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Critikon Company, LLC (Walker, US). The FDA issued a Cleared decision on July 20, 1984 after a review of 38 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K842316

510(k) Number K842316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date July 20, 1984
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 624
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K842316.
CARDIAC SUPPLY TRAY
K842645 · Deroyal Industries, Inc. · Aug 1984
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984
AXIOM FEMORAL VENUS CATHETER
K842084 · Axiom Medical, Inc. · Aug 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · Norton Performance Plastics Corp. · Jul 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · Gish Biomedical, Inc. · Jun 1984