510(k) · Cleared
ClearedSmarxt BMR 1900 Closed Venous Reservoir Bag
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 Mar 8, 2005 as substantially equivalent to K980786 (Cobe Cardiovascular, Inc., 1998) after a 49-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Mar 8, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980786 (1998). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980786 Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and…Cobe Cardiovascular, Inc. · 1998
- This deviceK050111 Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK112771 BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011
- Descendant · cites it directly · 1 of its ownK070605 Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG · 2008
- Descendant · 2 generations on · 0 of its ownK223361 BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
- Descendant · 2 generations on · 0 of its ownK161733 Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L. · 2017
- Descendant · 2 generations on · 0 of its ownK090690 Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG · 2009
Most influential descendants
Showing 5 of 5 · See all- K112771BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011 · cites it directly2descendants
- K070605Jostra Venous Softbag Reservoirs with and Without Safeline CoatingMaquet Cardiopulmonary, AG · 2008 · cites it directly1descendant
- K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023 · 2 generations on0descendants
- K161733Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L. · 2017 · 2 generations on0descendants
- K090690Venous Softbag Reservoirs with Softline CoatingMaquet Cardiopulmonary, AG · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980786 | Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800 | Cobe Cardiovascular, Inc. | 1998 | — |
| 0 (this device) | K050111 | Smarxt BMR 1900 Closed Venous Reservoir Bag | Cobe Cardiovascular, Inc. | 2005 | — |
| +1 | K112771 | BMR1900 PH.I.S.I.O Venous Reservoir Bag | Sorin Group Italia S.R.L. | 2011 | — |
| +1 | K070605 | Jostra Venous Softbag Reservoirs with and Without Safeline Coating | Maquet Cardiopulmonary, AG | 2008 | — |
| +2 | K223361 | BMR 1900 Phisio | Sorin Group Italia S.R.L. | 2023 | — |
| +2 | K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F C | Sorin Group Italia S.R.L. | 2017 | — |
| +2 | K090690 | Venous Softbag Reservoirs with Softline Coating | Maquet Cardiopulmonary, AG | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K980786 | Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800Summary page 1…nstrate that the COBE SMARxT BMR1900 Closed Venous Reservoir Bag is substantially equivalent to the currently marketed COBE SMARxT VRB1800 Closed Venous Reservoir Bag (K980786). 17 === Pa… | 1998 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K112771 (Sorin Group Italia S.R.L., 2011) has gone furthest, with 2 descendants 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 SMARxT® BMR1900TM Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050111
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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