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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Wood Burditt Group
H. Carl Jenkins

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 - FMI Needle, Hypodermic, Single Lumen

All 597
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K151311.
Sungshim Insulin Pen Needle
K152334 · Sung Shim Medicare Co., Ltd. · Mar 2016
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K152824 · Shandong Caremed Medical Products Co., Ltd. · Mar 2016
Pencylcap
K152050 · B.Braun Melsungen AG · Mar 2016
Top Fine Pen Needle
K152410 · Medexel Co.,Ltd · Feb 2016
Clickfine AutoProtect Pen Needle
K152514 · Ypsomed AG · Nov 2015
EXELINT SecureTouch Safety Hypodermic Needle
K152183 · Exelint International, Co. · Nov 2015