Cleared Special

K071222 - INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES

K071222 is an FDA 510(k) clearance for INFUSOR SV AND LV ELASTOMERIC INFUSION ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 23-day FDA review.

K071222 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
23d
Days
Class 2
Risk

K071222 is an FDA 510(k) clearance for the INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K071222

510(k) Number K071222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2007
Decision Date May 25, 2007
Days to Decision 23 days
Submission Type Special
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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MEB Pump, Infusion, Elastomeric

All 67
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K071222.
ALPHA INFUSION PUMP, MODEL A200, A450
K071532 · Advanced Infusion, Inc. · Feb 2008
SMARTBLOCK PAIN PUMP
K072053 · Medical Flow Systems, Ltd. · Nov 2007
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
K071735 · Symbios Medical Products, LLC · Jul 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
K061661 · Advanced Infusion, Inc. · Oct 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006