Cleared Traditional

K061159 - OPTICATH CENTRAL VENOUS OXIMETRY PROBE ...

K061159 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 Traditional 510(k) pathway after a 61-day FDA review.

K061159 · Hospira, Inc. · Cardiovascular device
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Jun 2006
Decision
61d
Days
Class 2
Risk

K061159 is an FDA 510(k) clearance for the OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT 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 June 26, 2006 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospira, Inc. devices

Submission Details

510(k) Number K061159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2006
Decision Date June 26, 2006
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K061159.
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999 · Hospira, Inc. · Nov 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · Hospira, Inc. · Oct 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450 · Hospira, Inc. · Aug 2006
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · Edwards Lifesciences, LLC · Apr 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K053609 · Edwards Lifesciences, LLC · Feb 2006
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · Baxter Healthcare Corp · Feb 1993