Cleared Special

K082212 - SYRINGE WITH HANDI-FIL

K082212 is an FDA 510(k) clearance for SYRINGE WITH HANDI-FIL, 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 169-day FDA review.

K082212 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K082212

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 197
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K082212.
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
K090621 · Flowcardia, Inc. · Jun 2009
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
K082439 · Shandong Weigao Medical Polymer Co., Ltd. · Mar 2009
MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
K083523 · Merit Medical Systems, Inc. · Feb 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905 · Medrad, Inc. · Jan 2009
OPTISTAR ELITE INJECTION SYSTEM
K073592 · Mallinckrodt Inc., Liebel-Flarsheim Business · May 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
K072696 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · May 2008
K082212 · SYRINGE WITH HANDI-FIL
Download PDF FDA Summary Mallinckrodt Inc., Li…