510(k) · Cleared
Recalled · Class II · 2021Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor
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 28, 2006 after a 63-day review. The FDA summary names its predicate without a number. 16 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 28, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- DQE
- Recalls
- 6
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK053609 Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure…Edwards Lifesciences, LLC · 2006
- Descendant · cites it directly · 11 of its ownK091786 Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox…Pulsion Medical Systems AG · 2010
- Descendant · 2 generations on · 10 of its ownK132075 Passport M Series Patient Monitoring (Including Models Passport 17M…Mindray North America · 2014
- Descendant · 3 generations on · 9 of its ownK143195 Passport Series Patient Monitors (including Passport 17M, Passport…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · Recalled
- Descendant · 4 generations on · 6 of its ownK152902 Passport Series Patient Monitors (including Passport 17m, Passport…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
- Descendant · 5 generations on · 3 of its ownK170876 Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K091786Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30…Pulsion Medical Systems AG · 2010 · cites it directly11descendants
- K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America · 2014 · 2 generations on10descendants
- K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 3 generations on9descendants
- K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 4 generations on6descendants
- K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac… | Edwards Lifesciences, LLC | 2006 | — |
| +1 | K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes… | Pulsion Medical Systems AG | 2010 | — |
| +2 | K132075 | Passport M Series Patient Monitoring (Including Models Passport 17M and… | Mindray North America | 2014 | — |
| +3 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 1 |
| +4 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 1 |
| +5 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | — | Central Venous Oximetry Probe Catheter and Probe Named without a submission number | |
| * | — | Multi-Med Multi-Lumen Central Venous Catheter Named without a submission number | |
| * | — | Edslab Dual Lumen Regional Saturation Oximetry Catheter Named without a submission number | |
| * | — | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor Named without a submission number | |
| * | — | SDM Percuglide Named without a submission number |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30… | 2010 | 11 |
| K061585 | Opticath Central Venous Oximetry Catheter | 2006 | 1 |
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central… | 2018 | 0 |
| K061159 | Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without Heparin | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2021 | Class II | Z-2283-2021 | Process control | There is a potential for internal leaks within catheters. |
| Jul 9, 2021 | Class II | Z-2282-2021 | Process control | There is a potential for internal leaks within catheters. |
| Jul 9, 2021 | Class II | Z-2279-2021 | Process control | There is a potential for internal leaks within catheters. |
| Jul 9, 2021 | Class II | Z-2280-2021 | Process control | There is a potential for internal leaks within catheters. |
| Jul 9, 2021 | Class II | Z-2278-2021 | Process control | There is a potential for internal leaks within catheters. |
| Jul 9, 2021 | Class II | Z-2281-2021 | Process control | There is a potential for internal leaks within catheters. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091786 (Pulsion Medical Systems AG, 2010) has gone furthest, with 11 descendants of its own.
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 PreSep Oximetry and PediaSat Oximetry Catheters are indicated for hemodynamic monitoring in adults and pediatrics through blood sampling, pressure monitoring and oxygen saturation measurement.
The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.
The Vigileo Arterial Pressure Cardiac Output /Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053609: Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053609
Report an extraction error
Are you the manufacturer?
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