Cleared Special

K071735 - MODIFICATION TO DISPOSABLE INFUSION PUMP KIT

K071735 is an FDA 510(k) clearance for MODIFICATION TO DISPOSABLE INFUSION PUM..., manufactured by Symbios Medical Products, LLC. 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.

K071735 · Symbios Medical Products, LLC · General Hospital
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Jul 2007
Decision
23d
Days
Class 2
Risk

K071735 is an FDA 510(k) clearance for the MODIFICATION TO DISPOSABLE INFUSION PUMP KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Symbios Medical Products, LLC (Indianapolis, US). The FDA issued a Cleared decision on July 19, 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 Symbios Medical Products, LLC devices

FDA 510(k) Submission Details - K071735

510(k) Number K071735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2007
Decision Date July 19, 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
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 49
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K071735.
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · Epic Medical Pte. , Ltd. · Oct 2024
ON-Q* Pump with Bolus
K181360 · Halyard Health · Mar 2019
SMARTez elastomeric infusion pump
K151650 · Epic Medical Pte. , Ltd. · Apr 2016
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