Cleared Traditional

K142535 - ConMed Mixing and Delivery Kit

K142535 is the FDA 510(k) clearance for ConMed Mixing and Delivery Kit by Conmed Corporation. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K142535 · Conmed Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
226d
Days
Class 2
Risk

K142535 is an FDA 510(k) clearance for the ConMed Mixing and Delivery Kit. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Conmed Corporation (Largo, US). The FDA issued a Cleared decision on April 23, 2015 after a review of 226 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 Conmed Corporation devices

Submission Details

510(k) Number K142535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2014
Decision Date April 23, 2015
Days to Decision 226 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
97d slower than avg
Panel avg: 129d · This submission: 226d
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 249
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K142535.
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
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