510(k) · Cleared
ClearedSorin Monolyth Venous Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Nov 2, 1993 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 35 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Nov 2, 1993
- Review
- 125 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 2 citing it directly. 3 of the 35 devices in this family, counting this one, have a Class I recall.
- This deviceK933481 Sorin Monolyth Venous ReservoirSorin Biomedical, Inc. · 1993
- Descendant · cites it directly · 33 of its ownK990103 Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated…Sorin Biomedical, Inc. · 1999
- Descendant · 2 generations on · 32 of its ownK031223 Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003
- Descendant · 3 generations on · 27 of its ownK073380 Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2008 · Recalled
- Descendant · 4 generations on · 21 of its ownK082117 Quadrox-I Adult with and Without Integrated Arterial Filter with…Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 5 generations on · 12 of its ownK090511 Quadrox-I Adult Microporous Membrane Oxygenator with Bioline…Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K990103Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous…Sorin Biomedical, Inc. · 1999 · cites it directly33descendants
- K031223Synthesis Mimesys Adult Membrane OxygenatorDideco S.P.A. · 2003 · 2 generations on32descendants
- K073380Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…Sorin Group Italia S.R.L. · 2008 · 3 generations on27descendants
- K082117Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…Maquet Cardiopulmonary, AG · 2009 · 4 generations on21descendants
- K090511Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…Maquet Cardiopulmonary, AG · 2009 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933481 | Sorin Monolyth Venous Reservoir | Sorin Biomedical, Inc. | 1993 | — |
| +1 | K990103 | Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell… | Sorin Biomedical, Inc. | 1999 | — |
| +2 | K031223 | Synthesis Mimesys Adult Membrane Oxygenator | Dideco S.P.A. | 2003 | — |
| +3 | K073380 | Synthesis PH.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial… | Sorin Group Italia S.R.L. | 2008 | 1 |
| +4 | K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline… | Maquet Cardiopulmonary, AG | 2009 | 5 |
| +5 | K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model… | Maquet Cardiopulmonary, AG | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 9 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 1 |
| 2013 | 3 | 0 |
| 2014 | 2 | 2 |
| 2015 | 2 | 0 |
| 2021 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (34)
See all 342 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal…Maquet Cardiopulmonary, AG · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K990103 (Sorin Biomedical, Inc., 1999) has gone furthest, with 33 descendants 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.
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 | — |
https://510kreport.com/device/K933481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933481: Sorin Monolyth Venous Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933481
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026