510(k) · Cleared
Recalled · Class II · 2021Sorin Centrifugal Pump 5 (CP5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Sep 20, 2011 as substantially equivalent to K103468 (Sorin Group Deutschland GmbH, 2011) and 1 other predicate after a 48-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 20, 2011
- Review
- 48 days
- Class
- Class II
- Product code
- DWA
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971520 (1997). 7 ancestors in all, the oldest K950990 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971520 S3 Cyclic RPM ControlStoeckert Instrumente · 1997
- 2 generations backK042374 Stockert SCP RhythmStockert Instrumente GmbH · 2004
- 1 generation backK071318 Modification to: Stockert S5 SystemSorin Group Deutschland GmbH · 2007 · Recalled
- This deviceK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011
- Descendant · cites it directly · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
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 |
|---|---|---|---|---|---|
| −3 | K971520 | S3 Cyclic RPM Control | Stoeckert Instrumente | 1997 | — |
| −2 | K042374 | Stockert SCP Rhythm | Stockert Instrumente GmbH | 2004 | — |
| −1 | K071318 | Modification to: Stockert S5 System | Sorin Group Deutschland GmbH | 2007 | 13 |
| 0 (this device) | K112225 | Sorin Centrifugal Pump 5 (CP5) | Sorin Group Deutschland GmbH | 2011 | — |
| +1 | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
| +2 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 DWA? 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 DWA device
- #1 K221491 Anivia SG1000 Pump Consolescore 9.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)Summary page 1…speed control device 870.4380; Product Code: DWA) 3. PREDICATE DEVICE/s * Stackert Centrifugal Pump System Plus for the S5/C5 System (K103468) * Pulse Mode Control for the S5 System (K07 1318) 4. DEVICE DESCRIPTION *Physical description… | 2011 |
| * | K071318 | Modification to: Stockert S5 SystemSummary page 1…; Product Code: DWA) 3. PREDICATE DEVICE/s * Stackert Centrifugal Pump System Plus for the S5/C5 System (K103468) * Pulse Mode Control for the S5 System (K07 1318) 4. DEVICE DESCRIPTION *Physical description… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221373 | Essenz HLM | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2021 | Class III | Z-0787-2022 | Process control | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| Oct 30, 2017 | Class II | Z-0401-2018 | Device Design | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system. |
| Dec 4, 2013 | Class II | Z-0857-2014 | Device Design | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response. |
| Feb 23, 2012 | Not classified | Z-1329-2012 | Nonconforming Material/Component | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K221373 (Livanova Deutschland, GmbH, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DWA devicesDWA Control, Pump Speed, 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 · DWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DWA
44in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWA
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DWA
362in 2025
MAUDE reports naming product code DWA, 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 | 1 | — | 0 | 10 |
| 2008 | 3 | 44 | 0 | 10 |
| 2009 | 2 | — | 0 | 17 |
| 2010 | 2 | — | 1 | 110 |
| 2011 | 2 | — | 0 | 147 |
| 2012 | 0 | — | 3 | 102 |
| 2013 | 2 | — | 1 | 100 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 103 |
| 2016 | 0 | — | 0 | 109 |
| 2017 | 0 | — | 1 | 140 |
| 2018 | 0 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 376 |
| 2020 | 2 | — | 0 | 146 |
| 2021 | 0 | — | 1 | 155 |
| 2022 | 0 | — | 1 (1) | 205 |
| 2023 | 2 | — | 0 | 438 |
| 2024 | 1 | — | 0 | 389 |
| 2025 | 0 | — | 0 | 362 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®5, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The 0P5 has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMVO) procedures.
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/K112225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112225: Sorin Centrifugal Pump 5 (CP5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112225
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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