Cleared Traditional

K840116 - DESERET INFANT CENTRAL VENOUS CATHE-

K840116 is an FDA 510(k) clearance for DESERET INFANT CENTRAL VENOUS CATHE-, manufactured by Parke-Davis Co.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K840116 · Parke-Davis Co. · General Hospital
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Mar 1984
Decision
71d
Days
Class 2
Risk

K840116 is an FDA 510(k) clearance for the DESERET INFANT CENTRAL VENOUS CATHE-. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 71 days - a notably fast clearance 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: 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 Parke-Davis Co. devices

FDA 510(k) Submission Details - K840116

510(k) Number K840116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1984
Decision Date March 22, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 344
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K840116.
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K840815 · Quinton, Inc. · Nov 1984
DESERET SUBCLAVIAN JUGULAR CATH. SET
K834227 · Parke-Davis Co. · Mar 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183 · Parke-Davis Co. · Mar 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840355 · Parke-Davis Co. · Mar 1984