510(k) · Cleared
Recalled · Class II · 2020Opticath Central Venous Oximetry Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · DQE Catheter, Oximeter, Fiber-Optic
Cleared on Oct 5, 2006 as substantially equivalent to K820674 (Oximetrix, Inc., 1982) and 2 other predicates after a 120-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 5, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- DQE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820674 (1982). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820674 | Opticath | Oximetrix, Inc. | 1982 | — |
| 0 (this device) | K061585 | Opticath Central Venous Oximetry Catheter | Hospira, Inc. | 2006 | — |
| +1 | K140129 | Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry… | Icu Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K820674 | OpticathSummary page 1…: OPTICATH® Central Venous Oximetry Catheter 5. Predicate Devices: OPTICATH® Oximetry Catheter (K820674) CVP Polyurethane Catheter (K961552) PreSep Cen… | 1982 |
| * | K961552 | CVP Polyurethane CatheterSummary page 1…Catheter 5. Predicate Devices: OPTICATH® Oximetry Catheter (K820674) CVP Polyurethane Catheter (K961552) PreSep Central Venous Oximetry Catheter (Edwards Life… | 1997 |
| * | K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…Summary page 1…olyurethane Catheter (K961552) PreSep Central Venous Oximetry Catheter (Edwards Lifesciences) (K053609) 6. Manufacturer and Establishment Registration Number: Manufacturer Site: Sterilization Site: ICU… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140129 | Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2020 | Class II | Z-2002-2020 | Process control | Inability for the guidewire to pass through the needles included with the catheter kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DQE devicesDQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQE
1in 2018
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
MAUDE reports naming product code DQE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 20 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 51 |
| 2010 | 0 | — | 0 | 64 |
| 2011 | 1 | — | 0 | 54 |
| 2012 | 0 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 38 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 1 | — | 0 | 68 |
| 2017 | 0 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 38 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 0 | — | 0 | 57 |
| 2023 | 0 | — | 0 | 48 |
| 2024 | 0 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 31 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and 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 OPTICATH® Central Venous Oximetry Catheter is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061585: Opticath Central Venous Oximetry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061585
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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