510(k) · Cleared
ClearedBMR1900 PH.I.S.I.O Venous Reservoir Bag
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 Oct 14, 2011 as substantially equivalent to K050111 (Cobe Cardiovascular, Inc., 2005) after a 21-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980786 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980786 Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and…Cobe Cardiovascular, Inc. · 1998
- 1 generation backK050111 Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
- This deviceK112771 BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011
- Descendant · cites it directly · 0 of its ownK223361 BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
- Descendant · cites it directly · 0 of its ownK161733 Inspire SVR 1200, Inspire 6F C, Inspire 8F CSorin Group Italia S.R.L. · 2017
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 |
|---|---|---|---|---|---|
| −2 | K980786 | Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800 | Cobe Cardiovascular, Inc. | 1998 | — |
| −1 | K050111 | Smarxt BMR 1900 Closed Venous Reservoir Bag | Cobe Cardiovascular, Inc. | 2005 | — |
| 0 (this device) | K112771 | BMR1900 PH.I.S.I.O Venous Reservoir Bag | Sorin Group Italia S.R.L. | 2011 | — |
| +1 | K223361 | BMR 1900 Phisio | Sorin Group Italia S.R.L. | 2023 | — |
| +1 | K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F C | Sorin Group Italia S.R.L. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050111 | Smarxt BMR 1900 Closed Venous Reservoir BagSummary page 1…Reservoir, Blood, Cardiopulmonary Bypass UNMODIFIED DEVICES: SMARxT BMR1 900 Closed Venous Reservoir Bag (K0501 11) DEVICE DESCRIPTION: The BMR1900 PH.I.S.I.O. is a sterile, non-pyrogenic softshell reservoir designed for use in cardiac surgic… | 2005 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223361 (Sorin Group Italia S.R.L., 2023) 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. 2011, 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 BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support 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/K112771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112771: BMR1900 PH.I.S.I.O 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/K112771
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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