Cleared Special

K062999 - OPTICATH CENTRAL VENOUS OXIMETRY PROBE ...

K062999 is the FDA 510(k) clearance for OPTICATH CENTRAL VENOUS OXIMETRY PROBE ... by Hospira, Inc.. It is a Class 2 Cardiovascular device (product code DQE) cleared through the Special 510(k) pathway after a 32-day FDA review.

K062999 · Hospira, Inc. · Cardiovascular device
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Nov 2006
Decision
32d
Days
Class 2
Risk

K062999 is an FDA 510(k) clearance for the OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN. Classified as Catheter, Oximeter, Fiber-optic (product code DQE), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 3, 2006 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1230 - 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. 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 Hospira, Inc. devices

Submission Details

510(k) Number K062999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date November 03, 2006
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQE Catheter, Oximeter, Fiber-optic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1230
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 - DQE Catheter, Oximeter, Fiber-optic

All 14
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K062999.
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K140129 · Icu Medical, Inc. · Jul 2014
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · Edwards Lifesciences, LLC · Feb 2011
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268 · Hospira, Inc. · Sep 2009
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · Hospira, Inc. · Oct 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450 · Hospira, Inc. · Aug 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159 · Hospira, Inc. · Jun 2006