510(k) · Cleared
ClearedQuantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DWA Control, Pump Speed, Cardiopulmonary Bypass
Cleared on Apr 13, 2020 as substantially equivalent to K011838 (Stockert Instrumente GmbH, 2002) after a 193-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 13, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- DWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991864 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK991864 Rotaflow Centrifugal Pump SystemJostra Medizintechnik AG · 2000 · Recalled
- 1 generation backK011838 Centrifugal PumpStockert Instrumente GmbH · 2002 · Recalled
- This deviceK192838 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal…Spectrum Medical, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K011838 | Centrifugal PumpSummary page 4…l and Vascular Devices) III. PREDICATE DEVICE The predicate device for this submission is the Sorin/LivaNova Stöckert Centrifugal Pump (K011838). IV. DEVICE DESCRIPTION The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping… | 2002 |
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 20 years and passes through 3 companies; a new generation was cleared every 18.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K011838.
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. 2020, 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 Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated
for use for exclusively with the Quantum Pureflow Centrifugal Blood Pump for speed-controlled pumping through the extracorporeal circuit for typical durations of six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192838: Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192838
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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