Cleared Abbreviated

K052667 - ARTSANA PISTON AND INSULIN SYRINGES

K052667 is an FDA 510(k) clearance for ARTSANA PISTON AND INSULIN SYRINGES, manufactured by Artsana S.P.A. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 59-day FDA review.

K052667 · Artsana S.P.A · General Hospital
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Nov 2005
Decision
59d
Days
Class 2
Risk

K052667 is an FDA 510(k) clearance for the ARTSANA PISTON AND INSULIN SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Artsana S.P.A (Bristol, US). The FDA issued a Cleared decision on November 25, 2005 after a review of 59 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 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 - K052667

510(k) Number K052667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date November 25, 2005
Days to Decision 59 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Standards-based clearance path.

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 342
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K052667.
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · Terumo Europe N.V. · Apr 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · Orthovita, Inc. · Oct 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · Nipro Medical Corp. · Aug 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · Terumo Medical Corp. · Aug 2005