510(k) · Cleared
ClearedQuantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical S.R.L. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Mar 12, 2026 as substantially equivalent to K202206 (Eurosets S.R.L, 2021) after a 212-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Mar 12, 2026
- Review
- 212 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K922933 (1992). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations between
- 3 generations backK102109 Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg…Eurosets S.R.L · 2011
- 2 generations backK141492 Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
- 1 generation backK202206 AMG PMP PediatricEurosets S.R.L · 2021
- This deviceK252541 Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026
Show all 9 generations
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 8 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 7 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 6 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 5 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 4 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 3 generations backK102109 Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg…Eurosets S.R.L · 2011
- 2 generations backK141492 Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
- 1 generation backK202206 AMG PMP PediatricEurosets S.R.L · 2021
- This deviceK252541 Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −8 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −7 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −6 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −5 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −4 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −3 | K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous… | Eurosets S.R.L | 2011 | — |
| −2 | K141492 | Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) | Eurosets S.R.L | 2015 | — |
| −1 | K202206 | AMG PMP Pediatric | Eurosets S.R.L | 2021 | — |
| 0 (this device) | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2015 | 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 K240908 Quantum Micro-Cardioplegia Delivery System…score 11.4 · 7 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 |
|---|---|---|---|
| * | K202206 | AMG PMP PediatricSummary page 5…(OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K202206 PREDICATE/REFERENCE DEVICE Proprietary Name: Quantum PureFlow Standard Heat Exchanger Medium… | 2021 |
| † | K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 6 of the 21 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. 2026, 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?
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 3.0 I/min.
Device is intended for pediatric patients (BSA according following characteristics: 0.6 m2 < BSA <1 m2)
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/K252541 · printed Nov 3, 2026
Cite this page
510(k) Report. “K252541: Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K252541
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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