510(k) · Cleared
ClearedSorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Aug 12, 2009 as substantially equivalent to K004046 (Cobe Cardiovascular, Inc., 2001) after a 13-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Aug 12, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K004046 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK004046 Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR…Cobe Cardiovascular, Inc. · 2001
- This deviceK092315 Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000… | Cobe Cardiovascular, Inc. | 2001 | — |
| 0 (this device) | K092315 | Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous Reservoir | Sorin Group Italia S.R.L. | 2009 | — |
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? (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 |
|---|---|---|---|
| * | K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered…Summary page 1…ardshell Venous Reservoirs (hereafter referred to as Unmodified WR 4000i) (#K004046) DEVICE DESCRIPTION: SORIN WR 4000i and SORIN WR 4000i SMARxT Filtered Hardshell Venous Reservoirs are sealed hardshell venous… | 2001 |
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?
- Its one ancestor has no recall.
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?
Sorin WR 4000i and Sorin WR 4000i SMARxT filtered hardshell reservoirs are intended to be used in surgical procedures requiring cardiopulmonary bypass for periods up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092315: Sorin VVR 4000I and 4000I Smarxt Filtered 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/K092315
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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