Cleared Traditional

K960616 - VITAFLOW SUCTION/ASPIRATION TUBING SET

K960616 is an FDA 510(k) clearance for VITAFLOW SUCTION/ASPIRATION TUBING SET, manufactured by Vital Concepts, Inc.. The device is a Class 2 General Hospital device with product code BYY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K960616 · Vital Concepts, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
83d
Days
Class 2
Risk

K960616 is an FDA 510(k) clearance for the VITAFLOW SUCTION/ASPIRATION TUBING SET. Classified as Tube, Aspirating, Flexible, Connecting (product code BYY), Class II - Special Controls.

Submitted by Vital Concepts, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Vital Concepts, Inc. devices

FDA 510(k) Submission Details - K960616

510(k) Number K960616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date May 06, 1996
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYY Device Classification - Class 2, Special Controls

Product Code BYY Tube, Aspirating, Flexible, Connecting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - BYY Tube, Aspirating, Flexible, Connecting

All 15
Devices cleared under the same product code (BYY) and FDA review panel - the closest regulatory comparables to K960616.
CONNECTING TUBING
K960218 · Custom Pack Reliability · Mar 1996
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
K955149 · Bio-Medical Devices, Inc. · Jan 1996
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
K955151 · Bio-Medical Devices, Inc. · Jan 1996
MAXI-FLOW
K955150 · Bio-Medical Devices, Inc. · Jan 1996
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K922989 · Wiltek Medical, Inc. · Feb 1994
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
K911586 · Megadyne Medical Products, Inc. · Jul 1991