Cleared Traditional

K061585 - OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061585 · Hospira, Inc. · Cardiovascular device
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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

Submission Details

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
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.

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.