Cleared Traditional

K791372 - JELCO & KVO CATHETER PLACEMENT UNIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K791372 · Jelco Laboratories · General & Plastic Surgery device
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Sep 1979
Decision
50d
Days
Class 1
Risk

K791372 is an FDA 510(k) clearance for the JELCO & KVO CATHETER PLACEMENT UNIT. Classified as Catheter, Infusion (product code JCY), Class I - General Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Jelco Laboratories devices

Submission Details

510(k) Number K791372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date September 12, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 114d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JCY Catheter, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.