510(k) · Cleared
ClearedPlegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Apr 4, 2008 as substantially equivalent to K012898 (Cobe Cardiovascular, Inc., 2001) and 1 other predicate after a 204-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it.
- Decided
- Apr 4, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932252 (1993). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 3 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 2 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 1 generation backK061072 Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 2006
- This deviceK072583 Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2008
- Descendant · cites it directly · 1 of its ownK090555 Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK112360 Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID…Maquet Cardiopulmonary, AG · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K090555Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30Maquet Cardiopulmonary, AG · 2009 · cites it directly1descendant
- K112360Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion Membrane…Maquet Cardiopulmonary, AG · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −3 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −2 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −1 | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 | Maquet Cardiopulmonary, AG | 2006 | — |
| 0 (this device) | K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30… | Maquet Cardiopulmonary, AG | 2008 | — |
| +1 | K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 | Maquet Cardiopulmonary, AG | 2009 | 1 |
| +2 | K112360 | Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-ID Diffusion… | Maquet Cardiopulmonary, AG | 2011 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 DTR? 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 DTR device
- #1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K012898 | Modification to: CSC14 Blood Cardioplegia System | 2001 |
| * | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Summary page 1…Cardiovascular Inc. (KO12898) and Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072), Maquet Cardiopulmonary AG. Device Description The Plegiox is a product, which is delivered to the end user in a pyrogen-free a… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-CHX 30 | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K090555 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K012898.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DTR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTR
Too few DTR 510(k)s in any year since 2007 to give a median.
Recalls per year · DTR
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTR
44in 2025
MAUDE reports naming product code DTR, 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 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 24 | 43 |
| 2011 | 0 | — | 3 | 67 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 0 | — | 1 | 96 |
| 2016 | 0 | — | 0 | 60 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 75 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 2 | — | 0 | 23 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 44 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Plegiox heat exchanger is used to set and maintain the temperature (for given
flow rates and within the given temperature range) of blood cardioplegic and
crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no
longer than 6 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072583: Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model (S) CHX30, BSQ-CHX 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072583
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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