510(k) · Cleared
ClearedQuantum 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 Oct 18, 2018 as substantially equivalent to K173591 (Spectrum Medical, Ltd., 2018) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 18, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- DTX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931968 (1993). 20 ancestors in all, the oldest K802226 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 6 generations backK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
- 5 generations backK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
- 4 generations backK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
- 3 generations backK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- 2 generations backK110957 M4 MonitorSpectrum Medical, Llp · 2011
- 1 generation backK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- This deviceK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
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 |
|---|---|---|---|---|---|
| −7 | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio | 3M Health Care, Ltd. | 1993 | — |
| −6 | K062468 | Spectrum M2 Monitor | Spectrum Medical, Llp | 2006 | — |
| −5 | K071725 | M2 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −4 | K072131 | M3 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −3 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| −2 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| −1 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| 0 (this device) | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +1 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSummary page 4…D) Circulatory Support Devices Branch (CSDB) III. PREDICATE DEVICES The primary predicate device is Spectrum Medical’s Quantum Diagnostic Module (K173591) and an additional predicate device is LivaNova’s Stöckert Gas Blender (K101046). These predicates have not been subject to a des… | 2018 |
| * | K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemSummary page 4…ATE DEVICES The primary predicate device is Spectrum Medical’s Quantum Diagnostic Module (K173591) and an additional predicate device is LivaNova’s Stöckert Gas Blender (K101046). These predicates have not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Quantum Ventilation Module provid… | 2010 |
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 |
|---|---|---|---|
| K202733 | Quantum Ventilation Module | 2020 | 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 25 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K202733 (Spectrum Medical, Ltd., 2020) has gone furthest, with 1 descendant of its own.
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. 2018, 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 Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include: • Measurement of up to three blood flow channels and arterial and venous flow differential • Indication of gas bubbles • Extracorporeal…
Read the full statement (134 words)
The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include:
• Measurement of up to three blood flow channels and arterial and venous flow differential
• Indication of gas bubbles
• Extracorporeal gas flow measurements (O2, CO2, gas flow, and CO2 removal)
• Predicted PO2 and PCO2
• Temperature
• Up to three circuit pressure channels
• Reservoir level indication
• Two channels of vacuum
• Blend and control gas flow (air/O2/CO2)
The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181942: Quantum 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/K181942
Report an extraction error
Are you the manufacturer?
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