Cleared Abbreviated

K151311 - Safe Block Pen Needle

K151311 is an FDA 510(k) clearance for Safe Block Pen Needle, manufactured by Artsana S.P.A. The device is a Class 2 General Hospital device with product code FMI cleared through the Abbreviated 510(k) pathway after a 268-day FDA review.

K151311 · Artsana S.P.A · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
268d
Days
Class 2
Risk

K151311 is an FDA 510(k) clearance for the Safe Block Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Artsana S.P.A (Grandate, IT). The FDA issued a Cleared decision on February 10, 2016 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Artsana S.P.A devices

FDA 510(k) Submission Details - K151311

510(k) Number K151311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date February 10, 2016
Days to Decision 268 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
139d slower than avg
Panel avg: 129d · This submission: 268d
Pathway characteristics
Standards-based clearance path.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 305
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K151311.
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016
BD Eclipse Hypodermic Needle
K161170 · Becton, Dickinson and Company · May 2016
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · Terumo Europe N.V. · Jun 2015
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015
EZ-IO INTRAOSSEOUS INFUSION SYSTEM
K132583 · Vidacare Corporation · Feb 2014