Cleared Traditional

K083514 - TERUMO SYRINGE WITH/WITHOUT NEEDLE

K083514 is the FDA 510(k) clearance for TERUMO SYRINGE WITH/WITHOUT NEEDLE by Terumo Europe N.V.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K083514 · Terumo Europe N.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
177d
Days
Class 2
Risk

K083514 is an FDA 510(k) clearance for the TERUMO SYRINGE WITH/WITHOUT NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on May 22, 2009 after a review of 177 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.

View all Terumo Europe N.V. devices

Submission Details

510(k) Number K083514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2008
Decision Date May 22, 2009
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 129d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K083514.
COAXIAL APPLICATOR SYSTEM
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BD FLU+ SYRINGE
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MICROMYST APPLICATOR, MODEL 20-5000
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UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007