Cleared Traditional

K170218 - Vesco Medical NRFit Tip Syringes

K170218 is an FDA 510(k) clearance for Vesco Medical NRFit Tip Syringes, manufactured by Vesco Medical, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K170218 · Vesco Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
30d
Days
Class 2
Risk

K170218 is an FDA 510(k) clearance for the Vesco Medical NRFit Tip Syringes. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Vesco Medical, LLC (Columbus, US). The FDA issued a Cleared decision on February 24, 2017 after a review of 30 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 Vesco Medical, LLC devices

FDA 510(k) Submission Details - K170218

510(k) Number K170218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date February 24, 2017
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170218.
Merit Syringe
K173601 · Merit Medical Systems, Inc. · Jan 2018
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017
Graftgun Universal Graft Delivery System
K170675 · SurGenTec, LLC · Jul 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606 · Terumo Europe N.V. · Feb 2017
BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe
K162081 · Becton, Dickinson and Company · Dec 2016
BD U-500 INSULIN SYRINGE
K151870 · Becton, Dickinson and Company · Jul 2016