510(k) · Cleared
ClearedVenous Hardshell Cardiotomy Resevoir, Model VHK 4201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jostra AG · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jul 11, 2001 after a 236-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jul 11, 2001
- Review
- 236 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK003551 Venous Hardshell Cardiotomy Resevoir, Model VHK 4201Jostra AG · 2001
- Descendant · cites it directly · 3 of its ownK061743 Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model…Maquet Cardiopulmonary, AG · 2006
- Descendant · 2 generations on · 2 of its ownK090534 Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009
- Descendant · 3 generations on · 1 of its ownK102919 Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous…Maquet Cardiopulmonary, AG · 2011 · Recalled
- Descendant · 4 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…4 generations on · 2014
Most influential descendants
Showing 4 of 4 · See all- K061743Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum…Maquet Cardiopulmonary, AG · 2006 · cites it directly3descendants
- K090534Venous Hardshell Cardiotomy ReserviorsMaquet Cardiopulmonary, AG · 2009 · 2 generations on2descendants
- K102919Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy…Maquet Cardiopulmonary, AG · 2011 · 3 generations on1descendant
- K141432Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…Maquet Cardiopulmonary, AG · 2014 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003551 | Venous Hardshell Cardiotomy Resevoir, Model VHK 4201 | Jostra AG | 2001 | — |
| +1 | K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK… | Maquet Cardiopulmonary, AG | 2006 | — |
| +2 | K090534 | Venous Hardshell Cardiotomy Reserviors | Maquet Cardiopulmonary, AG | 2009 | — |
| +3 | K102919 | Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2011 | 2 |
| +4 | K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell… | Maquet Cardiopulmonary, AG | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 1 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061743 | Venous Hardshell Cardiotomy Reservoir W/Safeline Coating, Model BSQ-VHK 2000;Vacuum… | 2006 | 3 |
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 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K061743 (Maquet Cardiopulmonary, AG, 2006) has gone furthest, with 3 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/K003551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003551: Venous Hardshell Cardiotomy Resevoir, Model VHK 4201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003551
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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