510(k) · Cleared
ClearedBMR 1900 Phisio
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 Jun 10, 2023 as substantially equivalent to K112771 (Sorin Group Italia S.R.L., 2011) after a 219-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jun 10, 2023
- Review
- 219 days
- Class
- Class II
- Product code
- DTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980786 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK980786 Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and…Cobe Cardiovascular, Inc. · 1998
- 2 generations backK050111 Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
- 1 generation backK112771 BMR1900 PH.I.S.I.O Venous Reservoir BagSorin Group Italia S.R.L. · 2011
- This deviceK223361 BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980786 | Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800 | Cobe Cardiovascular, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K223361 | BMR 1900 Phisio | Sorin Group Italia S.R.L. | 2023 | — |
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 |
|---|---|---|---|
| * | K112771 | BMR1900 PH.I.S.I.O Venous Reservoir BagSummary page 5…R 1900 PHISIO Closed Venous Reservoir CONFIDENTIAL Page 7-1 510(k) NUMBER: K112771 BMR 1900 PHISIO Closed Venous Reservoir PR… | 2011 |
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K112771.
How does its category compare?
All DTN devicesDTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for
periods of up to six hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223361: BMR 1900 Phisio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223361
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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