Cleared Special

K052828 - DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)

K052828 is an FDA 510(k) clearance for DISPOSABLE TRANSPAC III INTEGRATED TRAN..., manufactured by Hospira, Inc.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Special 510(k) pathway after a 135-day FDA review.

K052828 · Hospira, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
135d
Days
Class 2
Risk

K052828 is an FDA 510(k) clearance for the DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT). Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on February 17, 2006 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device oversight 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. Standard predicate reliance. 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 - K052828

510(k) Number K052828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2005
Decision Date February 17, 2006
Days to Decision 135 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 128
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K052828 · DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
Download PDF FDA Summary Hospira, Inc.