510(k) · Cleared
ClearedCobe HVR 4000 Filtered and Nonfiltered Hardshell Venous Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jul 23, 1997 after a 78-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK971669 Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK984456 Cobe HVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK990239 Cobe VVR 4000 Filtered Hardshell Venous ReservoirCobe Cardiovascular, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971669 | Cobe HVR 4000 Filtered and Nonfiltered Hardshell Venous Reservoir | Cobe Cardiovascular, Inc. | 1997 | — |
| +1 | K984456 | Cobe HVR 4000 Filtered Hardshell Venous Reservoir | Cobe Cardiovascular, Inc. | 1999 | — |
| +2 | K990239 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir | Cobe Cardiovascular, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 12.3 · 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? (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 |
|---|---|---|---|
| * | — | Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T Named without a submission number |
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 |
|---|---|---|---|
| K984456 | Cobe HVR 4000 Filtered Hardshell Venous Reservoir | 1999 | 1 |
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?
- Of its descendants, K984456 (Cobe Cardiovascular, Inc., 1999) 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.
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 HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
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/K971669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971669: Cobe HVR 4000 Filtered and Nonfiltered Hardshell 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/K971669
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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