510(k) · Cleared
ClearedStockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)
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 Jan 20, 2011 as substantially equivalent to K091008 (Sorin Group Deutschland GmbH, 2009) after a 57-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.
- Decided
- Jan 20, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091008 (2009). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK091008 Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10…Sorin Group Deutschland GmbH · 2009
- This deviceK103468 Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)Sorin Group Deutschland GmbH · 2011
- Descendant · cites it directly · 2 of its ownK112225 Sorin Centrifugal Pump 5 (CP5)Sorin Group Deutschland GmbH · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK221373 Essenz HLMLivanova Deutschland, GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK232291 Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091008 | Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | 2009 | — |
| 0 (this device) | K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems) | Sorin Group Deutschland GmbH | 2011 | — |
| +1 | K112225 | Sorin Centrifugal Pump 5 (CP5) | Sorin Group Deutschland GmbH | 2011 | 4 |
| +2 | K221373 | Essenz HLM | Livanova Deutschland, GmbH | 2023 | — |
| +3 | K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K091008 | Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55Summary page 1…eed control device (2] CFR 8 70.4380; Product Code: D WA) 3. PREDICATE DEVICE/s *Stdckert Centrifugal Pump (SCP) Plus System - K091008 4. DEVICE DESCRIPTION " Physical description The SCP Plus System is intended for use as a component part of or opt… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112225 | Sorin Centrifugal Pump 5 (CP5) | 2011 | 2 |
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, K112225 (Sorin Group Deutschland GmbH, 2011) has gone furthest, with 2 descendants 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 Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy T/ECC.OT for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware…
Read the full statement (139 words)
The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy T/ECC.OT for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware versions of 3.0. or greater) and the Stockert Air Purge Control (APC) System.
The SCP Plus 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 (ECMO) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103468: Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103468
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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