Cleared Abbreviated

K052221 - AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP

K052221 is an FDA 510(k) clearance for AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP, manufactured by Sorenson Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Abbreviated 510(k) pathway after a 115-day FDA review.

K052221 · Sorenson Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
115d
Days
Class 2
Risk

K052221 is an FDA 510(k) clearance for the AMBIT PUSH & PLAY 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 December 8, 2005 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052221

510(k) Number K052221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date December 08, 2005
Days to Decision 115 days
Submission Type Abbreviated
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
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

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 K052221.
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K052221 · AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
Download PDF FDA Summary Sorenson Medical, Inc.