Cleared Special

K061409 - SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET

Also marketed or referenced as:
P49224N W/O CATHETER SET

K061409 is an FDA 510(k) clearance for SMARTINFUSER PAINPUMP, manufactured by Precise Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 25-day FDA review.

K061409 · Precise Medical Products, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
25d
Days
Class 2
Risk

K061409 is an FDA 510(k) clearance for the SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Precise Medical Products, Ltd. (Shlomi, IL). The FDA issued a Cleared decision on June 16, 2006 after a review of 25 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 Precise Medical Products, Ltd. devices

FDA 510(k) Submission Details - K061409

510(k) Number K061409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2006
Decision Date June 16, 2006
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
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 53
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K061409.
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · Baxter Healthcare Corp · May 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530 · I-Flow Corp. · Jan 2007
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · Baxter Healthcare Corporation · Sep 2006
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005