510(k) · Cleared
ClearedQuantum Mini Ventilation Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Ltd. · DTX Gas Control Unit, Cardiopulmonary Bypass
Cleared on May 4, 2021 as substantially equivalent to K202733 (Spectrum Medical, Ltd., 2020) after a 60-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- May 4, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- DTX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931968 (1993). 22 ancestors in all, the oldest K802226 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 5 generations between
- 3 generations backK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- 2 generations backK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- 1 generation backK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- This deviceK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 8 generations backK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
- 7 generations backK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
- 6 generations backK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
- 5 generations backK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- 4 generations backK110957 M4 MonitorSpectrum Medical, Llp · 2011
- 3 generations backK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- 2 generations backK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- 1 generation backK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- This deviceK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio | 3M Health Care, Ltd. | 1993 | — |
| −8 | K062468 | Spectrum M2 Monitor | Spectrum Medical, Llp | 2006 | — |
| −7 | K071725 | M2 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −6 | K072131 | M3 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −5 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| −4 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| −3 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| −2 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| −1 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
| 0 (this device) | K210669 | Quantum Mini Ventilation Module | Spectrum Medical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 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 DTX? 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 DTX device
- #1 K202733 Quantum Ventilation Modulescore 5.3 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K202733 | Quantum Ventilation ModuleSummary page 4…and Vascular Devices) III. PREDICATE DEVICE The predicate device for this submission is Spectrum Medical Ltd.’s Quantum Ventilation Module (K202733). This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Quantum Mini Ventilation Module is… | 2020 |
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 28 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
How does its category compare?
All DTX devicesDTX Gas Control Unit, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DTX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DTX
Too few DTX 510(k)s in any year since 2007 to give a median.
Recalls per year · DTX
No recall names DTX since 2007.
Adverse event reports per year · DTX
127in 2025
MAUDE reports naming product code DTX, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 48 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 1 | — | 0 | 63 |
| 2021 | 1 | — | 0 | 77 |
| 2022 | 0 | — | 0 | 69 |
| 2023 | 0 | — | 0 | 69 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 127 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantum Mini Ventilation Module is intended to provide independently regulated 02 outputs for a controlled flow of
02 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum
workstation.
The following parameters are provided by the Quantum Mini Ventilation Module:
* Control of gas flow (02)
* Extracorporeal gas flow measurements for 02
The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be
used by a patient or other untrained personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210669: Quantum Mini Ventilation Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210669
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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