Cleared Traditional

K063851 - AUTO-FILL SYRINGE KIT

K063851 is the FDA 510(k) clearance for AUTO-FILL SYRINGE KIT by Vascular Solutions, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K063851 · Vascular Solutions, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
29d
Days
Class 2
Risk

K063851 is an FDA 510(k) clearance for the AUTO-FILL SYRINGE KIT, MODEL 7600. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 29 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 Solutions, Inc. devices

Submission Details

510(k) Number K063851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date January 26, 2007
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K063851.
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007
CAPTION APPLICATOR
K063535 · Smith & Nephew, Inc. · Feb 2007
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613 · Terumo Medical Corp. · Dec 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006
INJEKT SYRINGE
K063280 · B.Braun Medical, Inc. · Nov 2006