Cleared Traditional

K955783 - VLV SA.EF INFUSION PORT EXTENSION SETS

K955783 is an FDA 510(k) clearance for VLV SA.EF INFUSION PORT EXTENSION SETS, manufactured by Vlv Associates, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K955783 · Vlv Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
48d
Days
Class 2
Risk

K955783 is an FDA 510(k) clearance for the VLV SA.EF INFUSION PORT EXTENSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Vlv Associates, Inc. (East Hanover, US). The FDA issued a Cleared decision on February 7, 1996 after a review of 48 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.

FDA 510(k) Submission Details - K955783

510(k) Number K955783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date February 07, 1996
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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 984
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K955783.
WINGED & SUBCUTANEOUS INFUSION SETS
K955709 · Distronic Sterile Products, Inc. · Feb 1996
VENTED SOLUTION SET
K955732 · Distronic Sterile Products, Inc. · Feb 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
K952852 · Critical Device Corp. · Feb 1996
VENIPUNCTURE KIT
K954823 · Winfield Industries · Jan 1996
ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET
K953746 · Arrow Intl., Inc. · Jan 1996
I.V. ADMINISTRATION SET CONNECTING DEVICE
K940832 · Sierra Medical Devices · Jan 1996
K955783 · VLV SA.EF INFUSION PORT EXTENSION SETS
Download PDF Vlv Associates, Inc.