Cleared Traditional

VIGGO CONNECTA 3-WAY INFUSION STOPCOCK (K850280) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850280 · Viggo Products · General Hospital
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Apr 1985
Decision
78d
Days
Class 2
Risk

K850280 is an FDA 510(k) clearance for the VIGGO CONNECTA 3-WAY INFUSION STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Viggo Products (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 78 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 Viggo Products devices

Submission Details

510(k) Number K850280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1985
Decision Date April 11, 1985
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 21
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K850280.
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · Ohmeda Medical · Apr 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980