510(k) · Cleared
ClearedM4 Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Medical, Llp · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on May 31, 2011 as substantially equivalent to K091908 (Spectrum Medical, Ltd., 2009) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- May 31, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931968 (1993). 11 ancestors in all, the oldest K854357 (1986). 4 later devices descend from it, 1 citing it directly.
- 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 backK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
- 1 generation backK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- This deviceK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · cites it directly · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · cites it directly3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 2 generations on2descendants
- K202733Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020 · 3 generations on1descendant
- K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021 · 4 generations on0descendants
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 | K072131 | M3 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| −1 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| 0 (this device) | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +1 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +3 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
| +4 | K210669 | Quantum Mini Ventilation Module | Spectrum Medical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K091908 | M3 MonitorSummary page 1…rood Gas Monitor Trade Name: M4 Monitor Classification Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY Predicate Devices: K091 908 Spectrum Medical - M3 Monitor. K972962 3M - CDI 500 Description of Proposed Device: The Spectrum M4 Monitor… | 2009 |
| * | K972962 | 3M Cdi Blood Parameter Monitoring System 500Summary page 1…ation Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY Predicate Devices: K091 908 Spectrum Medical - M3 Monitor. K972962 3M - CDI 500 Description of Proposed Device: The Spectrum M4 Monitor consists of a 10.4 inch high definition, touch s… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | 2018 | 3 |
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 18 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K173591 (Spectrum Medical, Ltd., 2018) has gone furthest, with 3 descendants of its own.
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. 2011, 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 M4 Monitor is for the non-invasive continuous monitoring of
02 saturation, hematocrit and haemoglobin concentration, blood flow, gaseous
emboli, Temperature, P0 2, and PCO 2 , in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by
them to set parameter specific alarms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110957: M4 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110957
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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