510(k) · Cleared
ClearedSoft Venous Reservoir (Svrxx) with GBS Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gish Biomedical, Inc. · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Mar 5, 2003 as substantially equivalent to K955046 (Gish Biomedical, Inc., 1996) after an 86-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Mar 5, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955046 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955046 Soft Venous ReservoirGish Biomedical, Inc. · 1996
- This deviceK024065 Soft Venous Reservoir (Svrxx) with GBS CoatingGish Biomedical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK082082 Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK050195 V-Bag with GBS CoatingGish Biomedical, Inc. · 2005
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 |
|---|---|---|---|---|---|
| −1 | K955046 | Soft Venous Reservoir | Gish Biomedical, Inc. | 1996 | — |
| 0 (this device) | K024065 | Soft Venous Reservoir (Svrxx) with GBS Coating | Gish Biomedical, Inc. | 2003 | — |
| +1 | K082082 | Gish SVR Soft Venous Reservoirs with HA Coating | Gish Biomedical, Inc. | 2009 | — |
| +1 | K050195 | V-Bag with GBS Coating | Gish Biomedical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K955046 | Soft Venous ReservoirSummary page 1…Classification Name: Reservoir, Blood, Cardiopulmonary Bypass 3. Predicate Devices: Gish Soft Venous Reservoir, Gish Biomedical, Inc., K955046. 4. Classifications Names & Citations: 21 CFR 870.4400, Reservoir, Blood, Cardiopulmonary Bypass, Class II, D… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Gish Soft Venous Reservoirs with GBSTMCoating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024065: Soft Venous Reservoir (Svrxx) with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024065
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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