Cleared Traditional

K954112 - VYGON LIFEVAC MID-LINE TRAY

K954112 is an FDA 510(k) clearance for VYGON LIFEVAC MID-LINE TRAY, manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K954112 · Vygon Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
283d
Days
Class 2
Risk

K954112 is an FDA 510(k) clearance for the VYGON LIFEVAC MID-LINE TRAY. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Vygon Corp. (Elizabeth, US). The FDA issued a Cleared decision on May 9, 1996 after a review of 283 days - an extended review cycle.

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 Vygon Corp. devices

FDA 510(k) Submission Details - K954112

510(k) Number K954112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date May 09, 1996
Days to Decision 283 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
154d slower than avg
Panel avg: 129d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K954112.
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226 · Johnson & Johnson Medical, Inc. · Dec 1996
MEDCOMP P-CATH
K953811 · Medcomp · Jul 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805 · Abbott Laboratories · Jun 1996
MIDMARK MIDLINE CATHETER
K951620 · Menlo Care, Inc. · Apr 1996
ABRM CATHETER
K950118 · Cook, Inc. · Feb 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335 · Micro Therapeutics, Inc. · Jan 1996