Cleared Traditional

K965030 - BRANNON ARTERIO-VENOUS PORTSYRINGE

K965030 is an FDA 510(k) clearance for BRANNON ARTERIO-VENOUS PORTSYRINGE, manufactured by Vascular Logics, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K965030 · Vascular Logics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
77d
Days
Class 2
Risk

K965030 is an FDA 510(k) clearance for the BRANNON ARTERIO-VENOUS PORTSYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Vascular Logics, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Vascular Logics, Inc. devices

FDA 510(k) Submission Details - K965030

510(k) Number K965030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date March 04, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 389
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K965030.
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
K964597 · Biosurgical Corp. · Sep 1997
RAMY PISTON SYRINGE
K971664 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
IRT LOCKING SYRINGE
K945410 · Interventional Research Technologies · Dec 1996
DRESSING CHANGE TRAYS
K963260 · Busse Hospital Disposables, Inc. · Nov 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996