Cleared Special

K033425 - AMBIT INTERMITTENT AMBULATORY INFUSION PUMP

K033425 is an FDA 510(k) clearance for AMBIT INTERMITTENT 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 10-day FDA review.

K033425 · Sorenson Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
10d
Days
Class 2
Risk

K033425 is an FDA 510(k) clearance for the AMBIT INTERMITTENT 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 10 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.

FDA 510(k) Submission Details - K033425

510(k) Number K033425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2003
Decision Date November 06, 2003
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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 727
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K033425.
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K032789 · American I.V. Products, Inc. · Oct 2003
BEELINE SYSTEM
K032642 · Mckinley, Inc. · Sep 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
K033425 · AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
Download PDF FDA Summary Sorenson Medical, Inc.