510(k) · Cleared
Recalled · Class I · 2018Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jul 7, 2014 as substantially equivalent to K102919 (Maquet Cardiopulmonary, AG, 2011) after a 38-day review. Its family tree reaches back 9 generations to 1992. 1 of the 31 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jul 7, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- DTN
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K922933 (1992). 30 ancestors in all, the oldest K842908 (1985). No later device cites it as a predicate yet. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations between
- 3 generations backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- 1 generation backK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011 · Recalled
- This deviceK141432 Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous…Maquet Cardiopulmonary, AG · 2014
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 backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- 2 generations backK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- 1 generation backK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011 · Recalled
- This deviceK141432 Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous…Maquet Cardiopulmonary, AG · 2014
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 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| −2 | K090534 | Venous Hardshell Cardiotomy Reserviors | Maquet Cardiopulmonary, AG | 2009 | — |
| −1 | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2011 | 2 |
| 0 (this device) | K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 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 DTN device
- #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 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 |
|---|---|---|---|
| * | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Summary page 1…21 CFR 870.4400; 21 CFR 870.4230; 21 CFR 870.4270 Predicate Device: Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SQFTLINE Coating (K102919). 06-2 MAQUET Cardiopulmonary AG Premarket Notification Special 51… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2018 | Class I | Z-0436-2019 | Nonconforming Material/Component | There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection. |
| Oct 25, 2018 | Class I | Z-0437-2019 | Nonconforming Material/Component | There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 30 ancestors have a recall of any class.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DTN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTN
38in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTN
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTN
8in 2025
MAUDE reports naming product code DTN, 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 | 2 | — | 1 | 10 |
| 2008 | 1 | — | 1 | 8 |
| 2009 | 7 | 211 | 1 | 10 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 2 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 4 | 79 | 0 | 47 |
| 2014 | 3 | 38 | 0 | 52 |
| 2015 | 2 | — | 0 | 27 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 2 | — | 1 | 3 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in
extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up
to 6 hours.
The reservoir can also be employed postoperatively as drainage and autotransfusion
reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was
removed from the thorax for the volume exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141432: Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141432
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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