510(k) · Cleared
ClearedVenous Hardshell Cardiotomy Reserviors
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 Dec 23, 2009 as substantially equivalent to K061743 (Maquet Cardiopulmonary, AG, 2006) and 1 other predicate after a 299-day review. Its family tree reaches back 7 generations to 1992. 1 of the 23 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 299 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922933 (1992). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 6 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 5 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 4 generations backK022450 Integrated Unit: Synthesis: Adult Membrane Oxygenator with…Dideco S.P.A. · 2002
- 3 generations backK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- 2 generations backK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- 1 generation backK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- This deviceK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- Descendant · cites it directly · 1 of its ownK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK141432 Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous…Maquet Cardiopulmonary, AG · 2014 · Recalled (Class I)
Class I recalls in this family
- K141432 Neonatal Venous Hardshell Cardiotomy Reservior…2 generations on · 2014
Most influential descendants
Showing 2 of 2 · See all- K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG · 2011 · cites it directly1descendant
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −6 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −5 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −4 | K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial… | Dideco S.P.A. | 2002 | — |
| −3 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| −2 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| −1 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| 0 (this device) | K090534 | Venous Hardshell Cardiotomy Reserviors | Maquet Cardiopulmonary, AG | 2009 | — |
| +1 | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2011 | 2 |
| +2 | K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2014 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 1 |
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 12.3 · 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? (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 |
|---|---|---|---|
| * | K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum… | 2006 |
| * | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Summary page 1…Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Sofiline Coating (K0821 17) Device Description The Venous Hardshell Cardiotomy Reservoir is a reservoir with integrated filters and a defoamer. It is design… | 2009 |
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 |
|---|---|---|---|
| K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy… | 2011 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K102919 (Maquet Cardiopulmonary, AG, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Cardiotomny Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, stor6…
Read the full statement (147 words)
The Venous Hardshell Cardiotomny Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, stor6 and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090534: Venous Hardshell Cardiotomy Reserviors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090534
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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