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
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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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 549
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K170218.
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
K170386 · Becton, Dickinson Company · Apr 2017
Freedom Syringe
K161812 · Procedure Products, Inc. · Mar 2017
Sterile Single-use Syringe with Needle
K163161 · Jiangxi Hongda Medical Equipment Group , Ltd. · Mar 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
ConceptoMed Luer-Jack Slip 10ml
K162057 · Conceptomed AS · Jan 2017
Disposable Insulin Syringe
K162180 · Berpu Medical Technology Co., Ltd. · Dec 2016

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.