510(k) · Cleared
ClearedPreSep Oligon Oximetry Catheter
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 Jun 16, 2016 as substantially equivalent to K060093 (Edwards Lifesciences, LLC, 2006) and 1 other predicate after a 101-day review. Its family tree reaches back 9 generations to 2000. 4 of the 27 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 16, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- DQE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 25 ancestors in all, the oldest K830256 (1983). 1 later device descends from it, 1 citing it directly. 4 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 1 generation backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- This deviceK160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
- Descendant · cites it directly · 0 of its ownK172423 PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards…Edwards Lifescience, LLC · 2018 · Recalled
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 1 generation backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- This deviceK160645 PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
Class I recalls in this family
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…direct predicate · 2007
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…2 generations back · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip2 generations back · 1986
Most influential descendants
Showing 1 of 1 · See all- K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −1 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| 0 (this device) | K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | 2016 | — |
| +1 | K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… | Edwards Lifescience, LLC | 2018 | 1 |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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 |
|---|---|---|---|
| * | K060093 | Presep Oligon Oximetry Catheters | 2006 |
| * | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterSummary page 4…tion Name Catheter, Oximeter, Fiberoptic (21 CFR 870.1230) Regulation Class/Product Code Class Il/ DQE Predicate Device(s) KO60093: PreSep Oligon Oximetry Catheters K071538: Arrow G+ Blue Plus Pressure Injectable Central Venous Catheter Device Description The PreSep Oligon Oximetry Catheter is a pre… | 2007 |
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 |
|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central… | 2018 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 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 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 13 of the 25 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K172423 (Edwards Lifescience, LLC, 2018) 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. 2016, 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 pressure injectable PreSep Oligon Oximetry 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.
When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.
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/K160645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160645: PreSep Oligon Oximetry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160645
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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