Cleared Traditional

UNITOX BOTOX SYRINGE (K123710) - FDA 510(k) Clearance

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

K123710 · Bio-Med USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
156d
Days
Class 2
Risk

K123710 is an FDA 510(k) clearance for the UNITOX BOTOX SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bio-Med USA, Inc. (Paterson, US). The FDA issued a Cleared decision on May 9, 2013 after a review of 156 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 Bio-Med USA, Inc. devices

Submission Details

510(k) Number K123710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2012
Decision Date May 09, 2013
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K123710.
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011