Cleared Traditional

K963981 - VYGON BIONECTOR WITH EXTENSION SET

K963981 is an FDA 510(k) clearance for VYGON BIONECTOR WITH EXTENSION SET, manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K963981 · Vygon Corp. · General Hospital
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Feb 1997
Decision
134d
Days
Class 2
Risk

K963981 is an FDA 510(k) clearance for the VYGON BIONECTOR WITH EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Vygon Corp. (West Cadwell, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 134 days - within the typical 510(k) review window.

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: 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 Vygon Corp. devices

FDA 510(k) Submission Details - K963981

510(k) Number K963981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1996
Decision Date February 14, 1997
Days to Decision 134 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 129d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K963981.
NIPRO DISPOSABLE SOLUTION INFUSION SET
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CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
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SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
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POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · Medtronic Minimed · Jan 1997
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K964456 · Medtronic Minimed · Jan 1997
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · Baxter Healthcare Corp · Oct 1996