Cleared Traditional

EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS (K842133) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842133 · Cardio Search, Inc. · General Hospital
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Feb 1985
Decision
265d
Days
Class 2
Risk

K842133 is an FDA 510(k) clearance for the EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Cardio Search, Inc. (Tampa, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 265 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Search, Inc. devices

Submission Details

510(k) Number K842133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date February 19, 1985
Days to Decision 265 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 129d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 128
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K842133.
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K854566 · Terumo Medical Corp. · Jan 1986
QUINTON INJECTION SEALING CAP
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QUINTON WHITE SEALING CAP
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K840815 · Quinton, Inc. · Nov 1984
INJECTION CAP
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