510(k) · Cleared
ClearedPresep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DQE Catheter, Oximeter, Fiber-Optic
Cleared on Feb 18, 2011 as substantially equivalent to K060093 (Edwards Lifesciences, LLC, 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Feb 18, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935170 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935170 Cardiovascular and Vascular Guidewire ModificationsLake Region Mfg., Inc. · 1994
- 1 generation backK100739 Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC · 2010
- This deviceK110167 Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
- Descendant · cites it directly · 0 of its ownK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935170 | Cardiovascular and Vascular Guidewire Modifications | Lake Region Mfg., Inc. | 1994 | — |
| −1 | K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010 | — |
| 0 (this device) | K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) | Edwards Lifesciences, LLC | 2011 | — |
| +1 | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060093 | Presep Oligon Oximetry CathetersSummary page 1…Catheters Classification Name: Catheter, Oximeter, Fiberoptic (21 CFR Part 870.1230) Product Class/ Code: Class II/ DQE Predicate Devices: K060093, PreSep Oligon Oximetry Catheters K100739, VolumeView System Device Description: The PreSep Ol… | 2006 |
| * | K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Summary page 1…(21 CFR Part 870.1230) Product Class/ Code: Class II/ DQE Predicate Devices: K060093, PreSep Oligon Oximetry Catheters K100739, VolumeView System Device Description: The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry mo… | 2010 |
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 |
|---|---|---|---|
| K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central… | 2012 | 0 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 16.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113565 (Edwards Lifesciences, LLC, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060093.
How does its category compare?
All DQE devicesDQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110167
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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