510(k) Report

510(k) · Cleared

Cleared

Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without Heparin

K061159510(k) TraditionalCleared Jun 26, 200661-day reviewClass II21 CFR 870.1230

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hospira, Inc. · DQE Catheter, Oximeter, Fiber-Optic

Cleared on Jun 26, 2006 as substantially equivalent to K820674 (Oximetrix, Inc., 1982) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1982.

Decided
Jun 26, 2006
Review
61 days
Class
Class II
Product code
DQE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K820674 (1982). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK820674 · Opticath · Oximetrix, Inc. · 1982198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K820674 · Opticath · Oximetrix, Inc. · 19820
  1. Root · 1 generation backK820674 OpticathOximetrix, Inc. · 1982
  2. This deviceK061159 Opticath Central Venous Oximetry Probe with Fluidic Seal…Hospira, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K820674OpticathOximetrix, Inc.1982—
0 (this device)K061159Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without HeparinHospira, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K061159, 1982–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K820674Opticath
Summary page 1
…has a lateral flush port for pressure monitoring or for infusion of fluids. The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include: 1) reducing the usable length of the probe and removing the guiding balloon since the probe i…
Oximetrix, Inc.1982—
*K053609Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…
Summary page 1
…OPTICATH Oximetry CatheterK807 (ICU Medical, Hospira, Inc.) PreSep Central Venous Oximetry K053609 Catheter (Edwards Lifesciences) 6. Proposed Device Description: The OPTICATH® Central Venous…
Edwards Lifesciences, LLC20066

Also cleared against K820674: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • 1 other device also cites its predicate K820674.

How does its category compare?

All DQE devices

DQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQE

1in 2018

2009: 12011: 12014: 12016: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQE

Too few DQE 510(k)s in any year since 2007 to give a median.

Recalls per year · DQE

No recall names DQE since 2007.

Adverse event reports per year · DQE

31in 2025

2007: 202008: 122009: 512010: 642011: 542012: 792013: 582014: 382015: 582016: 682017: 472018: 382019: 632020: 392021: 392022: 572023: 482024: 472025: 31
2007high 79 (2012) · low 12 (2008)2025

MAUDE reports naming product code DQE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—020
20080—012
20091—051
20100—064
20111—054
20120—079
20130—058
20141—038
20150—058
20161—068
20170—047
20181—038
20190—063
20200—039
20210—039
20220—057
20230—048
20240—047
20250—031
20260—0—

What is it indicated for?

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO 2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids

Indications for use as stated in the FDA summary.

Also cleared against K820674

1 other device cites the same predicate.

  • K061585Opticath Central Venous Oximetry CatheterHospira, Inc. · 20061 recall

More from Hospira, Inc.

52 FDA decisions under this applicant name. See the company

  • K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 20172 Class I recalls
  • K161036Hospira Extension Set, Hospira Primary SetHospira, Inc. · 2017
  • K160492Hospira Sapphire SetsHospira, Inc. · 2016
  • K160870Hospira Administration SetsHospira, Inc. · 2016
  • K143612LifeCare PCA Infusion SystemHospira, Inc. · 2016

Recent decisions in DQE

The DQE category page

  • K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter…Edwards Lifescience, LLC · 20181 recall
  • K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
  • K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc. · 2014
  • K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
  • K091268Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 20095 recalls

https://510kreport.com/device/K061159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061159: Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061159

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026