510(k) · Cleared
Recalled · Class II · 2020PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifescience, LLC · DQE Catheter, Oximeter, Fiber-Optic
Cleared on Feb 20, 2018 as substantially equivalent to K053609 (Edwards Lifesciences, LLC, 2006) and 1 other predicate after a 194-day review. Its family tree reaches back 10 generations to 2000. 4 of the 28 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Feb 20, 2018
- Review
- 194 days
- Class
- Class II
- Product code
- DQE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K001901 (2000). 27 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 4 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- 1 generation backK160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
- This deviceK172423 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards…Edwards Lifescience, LLC · 2018
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- 1 generation backK160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
- This deviceK172423 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards…Edwards Lifescience, LLC · 2018
Class I recalls in this family
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…2 generations back · 2007
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter3 generations back · 1990
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip3 generations back · 1986
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −5 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −4 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −3 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −2 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| −1 | K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | 2016 | — |
| 0 (this device) | K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… | Edwards Lifescience, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 1 | 0 |
| 1990 | 1 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…Summary page 4…, Vessel, For Percutaneous Catheterization (21 CFR 870.1310) Regulation Class/ Class II/ Product Code: DQE, DRE Predicate K053609: PreSep (now EOCVC) & PediaSat Oximetry Catheters Device(s): (Primary Predicate) K160645: PreSep… | 2006 |
| * | K160645 | PreSep Oligon Oximetry CatheterSummary page 4…ct Code: DQE, DRE Predicate K053609: PreSep (now EOCVC) & PediaSat Oximetry Catheters Device(s): (Primary Predicate) K160645: PreSep (now EOCVC) Oligon Oximetry Catheter (Secondary Predicate) Device The Edwards Oxime… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2020 | Class II | Z-2007-2020 | Under Investigation by firm | Sterile catheter kit packaging compromised. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 27 ancestors have a recall of any class; 4 have a Class I recall.
- 3 other devices also cite its predicate K053609.
How does its category compare?
All DQE devicesDQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements, PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients. The pressure injectable EOCVC Oligon catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling…
Read the full statement (121 words)
The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements,
PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.
The pressure injectable EOCVC Oligon catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media, and central venous pressure monitoring,
The suture loop and box clamp are intended to be used to facilitate the suturing the catheter at the site of insertion.
The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172423: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172423
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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