510(k) · Cleared
ClearedQuantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
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 24, 2019 as substantially equivalent to K060053 (Sorin Group Deutschland GmbH, 2006) after a 102-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- May 24, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- DTQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060053 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060053 Stockert S5 SystemSorin Group Deutschland GmbH · 2006 · Recalled
- This deviceK190282 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH…Spectrum Medical, Ltd. · 2019
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) | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical, Ltd. | 2019 | — |
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 DTQ? 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 5…um Smart Occluder is an accessory to the Quantum Pump Console. The predicate devices for this submission are listed below: (Primary) - Sorin/LivaNova Stockert S5 System (K060053); (Reference) - Quantum Pump Console (K173834). (Reference) - Quantum Diagnostic Module (K173591) These predicates will be used… | 2006 |
| † | K173834 | Quantum Pump Console | 2018 |
| † | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | 2018 |
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?
- 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. 2019, 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 Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for 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/K190282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190282: Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190282
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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