510(k) · Cleared
Recalled · Class I · 2021OXY-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 Oct 23, 2020 as substantially equivalent to K191029 (Medtronic, Inc., 2019) and 2 other predicates after a 280-day review. Its family tree reaches back 6 generations to 1993. 1 of the 20 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Oct 23, 2020
- Review
- 280 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 6 generations to K932252 (1993). 17 ancestors in all, the oldest K771692 (1977). 2 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 5 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 4 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 3 generations backK061628 Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod…Maquet Cardiopulmonary, AG · 2006
- 2 generations backK071774 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating…Maquet Cardiopulmonary, AG · 2008
- 1 generation backK080592 HLM Tubing Set with Bioline CoatingMaquet Cardiopulmonary, AG · 2008 · Recalled
- This deviceK200109 OXY-1 SystemAbiomed, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK223161 OXY-1 SystemAbiomed, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222297 CentriMag Pre-connected PackAbbott · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −5 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −4 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −3 | K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030 | Maquet Cardiopulmonary, AG | 2006 | — |
| −2 | K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2008 | — |
| −1 | K080592 | HLM Tubing Set with Bioline Coating | Maquet Cardiopulmonary, AG | 2008 | 221 |
| 0 (this device) | K200109 | OXY-1 System | Abiomed, Inc. | 2020 | — |
| +1 | K223161 | OXY-1 System | Abiomed, Inc. | 2023 | — |
| +1 | K222297 | CentriMag Pre-connected Pack | Abbott | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma…Summary page 4…ary Bypass DWF – Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass III. PREDICATE DEVICE(S) Medtronic Affinity NT (Model 511) Oxygenator (K191029) Maquet, Rotaflow Pump (K991864) Maquet, Rotaflow Console (K991864) Maquet, HLM Tubing Set with Bioline coating (K080592) IV. DE… | 2019 |
| * | K991864 | Rotaflow Centrifugal Pump SystemSummary page 4…– Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass III. PREDICATE DEVICE(S) Medtronic Affinity NT (Model 511) Oxygenator (K191029) Maquet, Rotaflow Pump (K991864) Maquet, Rotaflow Console (K991864) Maquet, HLM Tubing Set with Bioline coating (K080592) IV. DEVICE DESCRIPTION The Breethe® O… | 2000 |
| * | K080592 | HLM Tubing Set with Bioline CoatingSummary page 4…) Medtronic Affinity NT (Model 511) Oxygenator (K191029) Maquet, Rotaflow Pump (K991864) Maquet, Rotaflow Console (K991864) Maquet, HLM Tubing Set with Bioline coating (K080592) IV. DEVICE DESCRIPTION The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypas… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2021 | Class I | Z-0550-2022 | Software design (manufacturing process) | The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K223161 (Abiomed, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K200109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200109: OXY-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200109
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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