Cleared Traditional

K013950 - VENTED VIAL ACCESS DEVICE

K013950 is an FDA 510(k) clearance for VENTED VIAL ACCESS DEVICE, manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K013950 · Churchill Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
41d
Days
Class 2
Risk

K013950 is an FDA 510(k) clearance for the VENTED VIAL ACCESS DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Dover, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 41 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 Churchill Medical Systems, Inc. devices

FDA 510(k) Submission Details - K013950

510(k) Number K013950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2001
Decision Date January 10, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 129d · This submission: 41d
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 726
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K013950.
LIFEGUARD SAFETY INFUSION SET
K013871 · Horizon Medical Products, Inc. · Mar 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · Sterling Medivations, Inc. · Jan 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · Sterling Medivations, Inc. · Jan 2002
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · Sterling Medivations, Inc. · Dec 2001
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
K013164 · Terumo Medical Corp. · Oct 2001
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
K013104 · Sterling Medivations, Inc. · Oct 2001