Cleared Traditional

K832624 - TOP VENULA I.V. CATHETER SET

K832624 is the FDA 510(k) clearance for TOP VENULA I.V. CATHETER SET by Top Surgical Manufacturers Co.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K832624 · Top Surgical Manufacturers Co. · General Hospital
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Nov 1983
Decision
109d
Days
Class 2
Risk

K832624 is an FDA 510(k) clearance for the TOP VENULA I.V. CATHETER SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Top Surgical Manufacturers Co. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 109 days - within the typical 510(k) review window.

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 Top Surgical Manufacturers Co. devices

Submission Details

510(k) Number K832624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date November 21, 1983
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 144
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K832624.
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