510(k) · Cleared
ClearedJostra Venous Softbag Reservoirs with and Without Safeline Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiopulmonary, AG · DTN Reservoir, Blood, Cardiopulmonary Bypass
Cleared on Jan 4, 2008 as substantially equivalent to K050111 (Cobe Cardiovascular, Inc., 2005) and 2 other predicates after a 305-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Jan 4, 2008
- Review
- 305 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932252 (1993). 8 ancestors in all, the oldest K920774 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
- 3 generations backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
- 2 generations backK030264 Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030Jostra AG · 2003
- 1 generation backK061072 Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Maquet Cardiopulmonary, AG · 2006
- This deviceK070605 Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG · 2008
- Descendant · cites it directly · 0 of its ownK090690 Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG · 2009
Most influential descendants
Showing 1 of 1 · See all- K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | 1993 | — |
| −3 | K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 | Jostra Bentley | 1999 | — |
| −2 | K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030 | Jostra AG | 2003 | — |
| −1 | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 | Maquet Cardiopulmonary, AG | 2006 | — |
| 0 (this device) | K070605 | Jostra Venous Softbag Reservoirs with and Without Safeline Coating | Maquet Cardiopulmonary, AG | 2008 | — |
| +1 | K090690 | Venous Softbag Reservoirs with Softline Coating | Maquet Cardiopulmonary, AG | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K050111 | Smarxt BMR 1900 Closed Venous Reservoir Bag | 2005 |
| * | K920774 | MVR Collapsible Venous Reservoir BagSummary page 1…Cardiovascular Inc. (KO50111), MVR 800 Collapsible Venous Reservoir Bag, Medtronic Inc. (K920774) RotaFlow Centrifugal Pump with Safeline Coating (K061072… | 1992 |
| * | K061072 | Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32Summary page 1…Medtronic Inc. (K920774) RotaFlow Centrifugal Pump with Safeline Coating (K061072) Device Description The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and se… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090690 | Venous Softbag Reservoirs with Softline Coating | 2009 | 0 |
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K090690 (Maquet Cardiopulmonary, AG, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050111.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070605: Jostra Venous Softbag Reservoirs with and Without Safeline Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070605
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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