510(k) · Cleared
ClearedBard Quantum SVR Model Number H-6440VR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Aug 5, 1998 as substantially equivalent to K935717 (Avecor Cardiovascular, Inc., 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 5, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920774 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920774 MVR Collapsible Venous Reservoir BagMedtronic Vascular · 1992
- This deviceK981628 Bard Quantum SVR Model Number H-6440VRC.R. Bard, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920774 | MVR Collapsible Venous Reservoir Bag | Medtronic Vascular | 1992 | — |
| 0 (this device) | K981628 | Bard Quantum SVR Model Number H-6440VR | C.R. Bard, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 DTN? 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? (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 |
|---|---|---|---|
| * | K935717 | Affinity Venous Reservior BagSummary page 1…iotomy and Venous Reservoir Classification Name: Cardiopulmonary Bypass Blood Reservoir Predicate Device Name(s): 1) Avecor Affinity 321 Softshell Venous Reservoir Bag, K935717 2) Medtronic MVR 1600 Softshell Venous Reservoir Bag, K920774 Device Description/Indications for Use: The Bard® Quantum™ SVR is… | 1994 |
| * | K920774 | MVR Collapsible Venous Reservoir BagSummary page 1…ry Bypass Blood Reservoir Predicate Device Name(s): 1) Avecor Affinity 321 Softshell Venous Reservoir Bag, K935717 2) Medtronic MVR 1600 Softshell Venous Reservoir Bag, K920774 Device Description/Indications for Use: The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexib… | 1992 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K935717.
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 | — |
What is it indicated for?
The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from:
(1) venous return
(2) suctioned blood from the cardiotomy reservoir
The venous reservoir stores this blood prior to returning it to the circuit.
The Bard® Quantum™ SVR is designed to function for up to 6 hours in an extracorporeal circuit.
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/K981628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981628: Bard Quantum SVR Model Number H-6440VR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981628
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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