Cleared Traditional

K122416 - ARTIGLASS L. O.R. GLASS SYRINGE

K122416 is an FDA 510(k) clearance for ARTIGLASS L. O.R. GLASS SYRINGE, manufactured by Artiglass Srl. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K122416 · Artiglass Srl · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
268d
Days
Class 2
Risk

K122416 is an FDA 510(k) clearance for the ARTIGLASS L. O.R. GLASS SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Artiglass Srl (Due Carrare Padova, IT). The FDA issued a Cleared decision on May 3, 2013 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122416

510(k) Number K122416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date May 03, 2013
Days to Decision 268 days
Submission Type Traditional
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
Predicate-based equivalence. No clinical trials required.

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 621
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K122416.
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766 · Novo Nordisk, Inc. · Aug 2013
EVICEL APPLICATION DEVICE
K130900 · Ethicon Inc (On Behalf of Omrix Biopharaceuticals · Aug 2013
UNITOX BOTOX SYRINGE
K123710 · Bio-Med USA, Inc. · May 2013
INTRADERMAL ADAPTER
K123588 · West Pharmaceutical Services, Inc. · Feb 2013
MONOJECT 12ML SYRINGE
K130049 · Nipro Medical Corporation · Feb 2013
COMFORT EZ
K122787 · Simple Diagnostics, Inc. · Dec 2012
K122416 · ARTIGLASS L. O.R. GLASS SYRINGE
Download PDF FDA Summary Artiglass Srl