Cleared Traditional

BIOMET GRAFT DELIVERY SYRINGES (K140710) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140710 · Biomet Spine (Aka Ebi, LLC) · General Hospital
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Sep 2014
Decision
167d
Days
Class 2
Risk

K140710 is an FDA 510(k) clearance for the BIOMET GRAFT DELIVERY SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 4, 2014 after a review of 167 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 Biomet Spine (Aka Ebi, LLC) devices

Submission Details

510(k) Number K140710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date September 04, 2014
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K140710.
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011