510(k) · Cleared
Recalled · Class II · 2026Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quara S.R.L. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Apr 13, 2023 as substantially equivalent to K220110 (Qura S.R.L, 2022) after a 107-day review. Its family tree reaches back 8 generations to 1992. It has been recalled 2 times.
- Decided
- Apr 13, 2023
- Review
- 107 days
- Class
- Class II
- Product code
- DTR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K922933 (1992). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 7 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 6 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 5 generations backK020997 Apex PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDideco S.P.A. · 2002 · Recalled
- 4 generations backK083021 Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2008 · Recalled
- 3 generations backK092895 Apex HP M Adult Hollow Fiber Membrane OxygenatorSorin Group Italia S.R.L. · 2009 · Recalled
- 2 generations backK212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow…Qura S.R.L · 2022
- 1 generation backK220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow…Qura S.R.L · 2022 · Recalled
- This deviceK223879 Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and…Quara S.R.L. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −7 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −6 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −5 | K020997 | Apex PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Dideco S.P.A. | 2002 | 2 |
| −4 | K083021 | Apex HP M PH.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2008 | 2 |
| −3 | K092895 | Apex HP M Adult Hollow Fiber Membrane Oxygenator | Sorin Group Italia S.R.L. | 2009 | 1 |
| −2 | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat… | Qura S.R.L | 2022 | — |
| −1 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia… | Qura S.R.L | 2022 | 2 |
| 0 (this device) | K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerSummary page 4…T2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K220110 Page 1… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2026 | Class II | Z-3327-2026 | Process design | Due to blood-to-glycol leak in the heat exchanger. |
| Jul 17, 2026 | Class II | Z-3328-2026 | Process design | Due to blood-to-glycol leak in the heat exchanger. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 6 of the 13 ancestors have a recall of any class.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, 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 · 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 Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to
heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration.
Devices are intended for adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223879: Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223879
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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