Cleared Traditional

K781190 - INFUSION SET

K781190 is the FDA 510(k) clearance for INFUSION SET by Venospital, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K781190 · Venospital, Inc. · General Hospital
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Aug 1978
Decision
27d
Days
Class 2
Risk

K781190 is an FDA 510(k) clearance for the INFUSION SET, VENOTHIN 21. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Venospital, Inc. devices

Submission Details

510(k) Number K781190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date August 10, 1978
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 486
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K781190.
IV SET WITH GRADUATED CHAMBER
K781744 · National Patent Development Corp. · Dec 1978
SOLUTION ADMINISTRATION, FLEX VALVE
K781812 · Travenol Laboratories, S.A. · Dec 1978
AUTO-SYRINGE INFUSION SET
K781036 · Baxter Healthcare Corp · Aug 1978
BURETTE SET WITH AIR CONTROL LEVER
K780970 · Travenol Laboratories, S.A. · Jul 1978
I.V. ADMINISTRATION SET WITH MINI-SPIKE
K780551 · National Patent Development Corp. · Apr 1978
I.V. LEVER CLAMP
K780481 · Travenol Laboratories, S.A. · Apr 1978