Cleared Special

SYRINGE WITH HANDI-FIL (K082212) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082212 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
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Jan 2009
Decision
169d
Days
Class 2
Risk

K082212 is an FDA 510(k) clearance for the SYRINGE WITH HANDI-FIL. 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 January 22, 2009 after a review of 169 days - an extended review 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. Standard predicate reliance. 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

Submission Details

510(k) Number K082212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date January 22, 2009
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 209
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