Cleared Traditional

K770863 - FLU VEN 0160

K770863 is the FDA 510(k) clearance for FLU VEN 0160 by Venospital, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K770863 · Venospital, Inc. · General Hospital
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Jun 1977
Decision
34d
Days
Class 2
Risk

K770863 is an FDA 510(k) clearance for the FLU VEN 0160. 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 June 14, 1977 after a review of 34 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 K770863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1977
Decision Date June 14, 1977
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 K770863.
FLUID HANDLING DEVICE W/INPUT TUBING
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K770743 · Abbott Laboratories · Jun 1977
BURETTE SET, 2C0132
K770763 · Travenol Laboratories, S.A. · Jun 1977
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K770744 · Abbott Laboratories · May 1977
PIGGYBACK VENOSET W/0.22 FILTER
K770518 · Abbott Laboratories · Apr 1977