510(k) · Cleared
ClearedQuantum Workstation
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 Jan 18, 2017 as substantially equivalent to K071725 (Spectrum Medical, Ltd., 2007) after a 26-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jan 18, 2017
- Review
- 26 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931968 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 2 generations backK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
- 1 generation backK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
- This deviceK163657 Quantum WorkstationSpectrum Medical, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK181923 Quantum Workstation 12.1Spectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK202557 Quantum Workstation 12 EliteSpectrum Medical, Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio | 3M Health Care, Ltd. | 1993 | — |
| −2 | K062468 | Spectrum M2 Monitor | Spectrum Medical, Llp | 2006 | — |
| −1 | K071725 | M2 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| 0 (this device) | K163657 | Quantum Workstation | Spectrum Medical, Ltd. | 2017 | — |
| +1 | K181923 | Quantum Workstation 12.1 | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K202557 | Quantum Workstation 12 Elite | Spectrum Medical, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 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 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
- #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 |
|---|---|---|---|
| * | K071725 | M2 MonitorSummary page 4…Division of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) III. PREDICATE DEVICE Spectrum Medical Ltd’s M2 Monitor (K071725) This predicate has not been subject to a design-related recall. No reference devices were used in this submission. === Page 5 =… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181923 | Quantum Workstation 12.1 | 2018 | 1 |
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 24 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181923 (Spectrum Medical, Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071725.
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. 2017, 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 is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation is configured to measure and display the following measurements: SaO2 Arterial Saturation (%) SvO2 Venous Saturation (%) Hb Hemoglobin (g/L and gm/dl) Hct Calculated Hematocrit (%) The Workstation…
Read the full statement (114 words)
The intended use of the Quantum Workstation is for the non-invasive continuous monitoring of oxygen saturation and
hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the
Quantum Workstation is configured to measure and display the following measurements:
SaO2 Arterial Saturation (%)
SvO2 Venous Saturation (%)
Hb Hemoglobin (g/L and gm/dl)
Hct Calculated Hematocrit (%)
The Workstation 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 as stated in the FDA summary.
https://510kreport.com/device/K163657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163657: Quantum Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163657
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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