Cleared Special

K022116 - ELPH INJECTION SYSTEM

K022116 is an FDA 510(k) clearance for ELPH INJECTION SYSTEM, manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Special 510(k) pathway after a 25-day FDA review.

K022116 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
25d
Days
Class 2
Risk

K022116 is an FDA 510(k) clearance for the ELPH INJECTION SYSTEM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, US). The FDA issued a Cleared decision on July 26, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mallinckrodt Inc., Liebel-Flarsheim Business devices

FDA 510(k) Submission Details - K022116

510(k) Number K022116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date July 26, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 129
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K022116.
MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K033247 · Medrad, Inc. · Nov 2003
MEDRAD MANUAL SYRINGE LOADER
K031483 · Medrad, Inc. · Aug 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · Medrad, Inc. · Jan 2003
MEDRAD QWIK-FIT SYRINGE
K013815 · Medrad, Inc. · Dec 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · Medrad, Inc. · Oct 2001
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc. · Aug 2001