Cleared Special

K063530 - ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP

K063530 is an FDA 510(k) clearance for ON-Q, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 65-day FDA review.

K063530 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
65d
Days
Class 2
Risk

K063530 is an FDA 510(k) clearance for the ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIE.... Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 65 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 I-Flow Corp. devices

FDA 510(k) Submission Details - K063530

510(k) Number K063530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date January 26, 2007
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 76
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K063530.
SMARTBLOCK PAIN PUMP
K072053 · Medical Flow Systems, Ltd. · Nov 2007
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
K071735 · Symbios Medical Products, LLC · Jul 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 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
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET
K061409 · Precise Medical Products, Ltd. · Jun 2006