510(k) · Cleared
ClearedQuantum Workstation 12 Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Oct 2, 2020 as substantially equivalent to K181923 (Spectrum Medical, Ltd., 2018) after a 29-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Oct 2, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931968 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 4 generations backK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
- 3 generations backK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
- 2 generations backK163657 Quantum WorkstationSpectrum Medical, Ltd. · 2017
- 1 generation backK181923 Quantum Workstation 12.1Spectrum Medical, Ltd. · 2018
- This deviceK202557 Quantum Workstation 12 EliteSpectrum Medical, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio | 3M Health Care, Ltd. | 1993 | — |
| −4 | K062468 | Spectrum M2 Monitor | Spectrum Medical, Llp | 2006 | — |
| −3 | K071725 | M2 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −2 | K163657 | Quantum Workstation | Spectrum Medical, Ltd. | 2017 | — |
| −1 | K181923 | Quantum Workstation 12.1 | Spectrum Medical, Ltd. | 2018 | — |
| 0 (this device) | K202557 | Quantum Workstation 12 Elite | Spectrum Medical, Ltd. | 2020 | — |
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 DRY? 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 DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K181923 | Quantum Workstation 12.1Summary page 4…Vascular Devices) III. PREDICATE DEVICE The predicate device for this submission is Spectrum Medical Ltd.’s Quantum Workstation 12.1” (K181923). This predicate has not been subject to a design-related recall. Three reference devices manufactured by Spectrum Medical Ltd. w… | 2018 |
| † | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | 2018 |
| † | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | 2019 |
| † | K173834 | Quantum Pump Console | 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, 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 · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements: * Sa02 Arterial Saturation (%) * SvO2 Venous Saturation (%) * Hb Hemoglobin (g/L and gm/dl) » Het Calculated…
Read the full statement (145 words)
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements:
* Sa02 Arterial Saturation (%)
* SvO2 Venous Saturation (%)
* Hb Hemoglobin (g/L and gm/dl)
» Het Calculated Hematocrit (%)
* Blood Flow - 2 channels with arterial and venous flow differentials
* Pressure & Temperature - 4 channels
The Quantum Workstation 12” Elite provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The workstation’s monitoring and alarm functionality does not directly control patient care. The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the workstation.
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/K202557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202557: Quantum Workstation 12 Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202557
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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