Cleared Special

K061573 - TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

K061573 is an FDA 510(k) clearance for TRANSPAC III DISPOSABLE STRAIGHT PRESSU..., 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 104-day FDA review.

K061573 · Hospira, Inc. · Cardiovascular device
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Sep 2006
Decision
104d
Days
Class 2
Risk

K061573 is an FDA 510(k) clearance for the TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT. 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 September 19, 2006 after a review of 104 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.

View all Hospira, Inc. devices

FDA 510(k) Submission Details - K061573

510(k) Number K061573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2006
Decision Date September 19, 2006
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 97
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