510(k) · Cleared
Recalled · Class I · 2023Quantum Pump Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Cleared on May 25, 2018 as substantially equivalent to K060053 (Sorin Group Deutschland GmbH, 2006) after a 158-day review. Its family tree reaches back 1 generation to 2006. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- May 25, 2018
- Review
- 158 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060053 (2006). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK060053 Stockert S5 SystemSorin Group Deutschland GmbH · 2006 · Recalled
- This deviceK173834 Quantum Pump ConsoleSpectrum Medical, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060053 | Stockert S5 System | Sorin Group Deutschland GmbH | 2006 | 20 |
| 0 (this device) | K173834 | Quantum Pump Console | Spectrum Medical, Ltd. | 2018 | — |
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.
1 device in this family has a Class I recall. 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 DTQ device
- #1 K221373 Essenz HLMscore 8.9 · 4 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 |
|---|---|---|---|
| * | K060053 | Stockert S5 SystemSummary page 4…Division of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) III. PREDICATE DEVICE Stöckert S5 System (K060053) currently marketed by LivaNova IV. DEVICE DESCRIPTION The Quantum Pump Console is a configurable heart-lung machine consisting… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2023 | Class II | Z-0224-2025 | Component design/selection | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. |
| May 29, 2019 | Class I | Z-2238-2019 | Software design | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K060053.
How does its category compare?
All DTQ devicesDTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DTQ
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DTQ
292in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTQ
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DTQ
1,014in 2025
MAUDE reports naming product code DTQ, 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 | — | 9 | 420 |
| 2008 | 1 | — | 17 | 548 |
| 2009 | 3 | 86 | 1 | 589 |
| 2010 | 1 | — | 17 | 811 |
| 2011 | 2 | — | 22 | 1,081 |
| 2012 | 0 | — | 42 | 1,626 |
| 2013 | 0 | — | 4 | 906 |
| 2014 | 2 | — | 1 | 1,290 |
| 2015 | 2 | — | 0 | 1,184 |
| 2016 | 0 | — | 0 | 714 |
| 2017 | 2 | — | 0 | 527 |
| 2018 | 1 | — | 1 | 676 |
| 2019 | 1 | — | 1 (1) | 857 |
| 2020 | 0 | — | 0 | 627 |
| 2021 | 2 | — | 0 | 729 |
| 2022 | 0 | — | 1 | 717 |
| 2023 | 3 | 292 | 7 (1) | 818 |
| 2024 | 0 | — | 1 | 863 |
| 2025 | 0 | — | 0 | 1,014 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173834: Quantum Pump Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173834
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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