Cleared Abbreviated

K163597 - VacLok AT Vacuum Syringe (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K163597 · Merit Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
218d
Days
Class 2
Risk

K163597 is an FDA 510(k) clearance for the VacLok AT Vacuum Syringe. Classified as Vacuum Syringe (product code PUR), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 27, 2017 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K163597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2016
Decision Date July 27, 2017
Days to Decision 218 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 128d · This submission: 218d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PUR Vacuum Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition The Vacuum Syringe Is Intended To Be Used As A General Purpose Syringe For Injection And Withdrawal Of Fluids And Can Be Locked In Place To Create A Vacuum For Removal Of Fluid And/or Tissue From The Body In The Form Of Thrombus, Abscess Fluid, And Infected Fluid.
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.