510(k) · Cleared
ClearedOXY-1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 23, 2023 as substantially equivalent to K200109 (Abiomed, Inc., 2020) after a 139-day review. Its family tree reaches back 7 generations to 1993. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 23, 2023
- Review
- 139 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K932252 (1993). 18 ancestors in all, the oldest K771692 (1977). No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 6 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 5 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 4 generations backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- 3 generations backK071774 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG · 2008
- 2 generations backK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
- 1 generation backK200109 OXY-1 SystemAbiomed, Inc. · 2020 · Recalled (Class I)
- This deviceK223161 OXY-1 SystemAbiomed, Inc. · 2023
Class I recalls in this family
- K200109 OXY-1 Systemdirect predicate · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −6 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −5 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −4 | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| −3 | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2008 | — |
| −2 | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | 221 |
| −1 | K200109 | OXY-1 System | Abiomed, Inc. | 2020 | Class I |
| 0 (this device) | K223161 | OXY-1 System | Abiomed, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K200109 | OXY-1 SystemSummary page 4…Tubing, Vascular, Cardiopulmonary Bypass C. Predicate Device: The primary predicate device was the OXY-1 System, which is cleared under K200109. D. Device Description: The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K200109OXY-1 SystemAbiomed, Inc. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 7 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K200109.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223161: OXY-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223161
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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