Cleared Traditional

K061585 - OPTICATH CENTRAL VENOUS OXIMETRY CATHETER

K061585 is an FDA 510(k) clearance for OPTICATH CENTRAL VENOUS OXIMETRY CATHETER, manufactured by Hospira, Inc.. The device is a Class 2 Cardiovascular device with product code DQE cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K061585 · Hospira, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2006
Decision
120d
Days
Class 2
Risk

K061585 is an FDA 510(k) clearance for the OPTICATH CENTRAL VENOUS OXIMETRY CATHETER. 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 October 5, 2006 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1230 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hospira, Inc. devices

FDA 510(k) Submission Details - K061585

510(k) Number K061585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2006
Decision Date October 05, 2006
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQE Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K061585.
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K062999 · Hospira, Inc. · Nov 2006
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K061450 · Hospira, Inc. · Aug 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159 · Hospira, Inc. · Jun 2006
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · Edwards Lifesciences, LLC · Apr 2006