Cleared Special

K033325 - AMBIT CONTINUOUS AMBULATORY INFUSION PUMP

K033325 is an FDA 510(k) clearance for AMBIT CONTINUOUS AMBULATORY INFUSION PUMP, manufactured by Sorenson Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 21-day FDA review.

K033325 · Sorenson Medical, Inc. · General Hospital
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Nov 2003
Decision
21d
Days
Class 2
Risk

K033325 is an FDA 510(k) clearance for the AMBIT CONTINUOUS AMBULATORY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sorenson Medical, Inc. (West Jordan, US). The FDA issued a Cleared decision on November 6, 2003 after a review of 21 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 Sorenson Medical, Inc. devices

FDA 510(k) Submission Details - K033325

510(k) Number K033325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2003
Decision Date November 06, 2003
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 543
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K033325.
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · Medex, Inc. · Apr 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · Medtronic Minimed · Apr 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003
SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
K032147 · Alaris Medical Systems, Inc. · Jul 2003