510(k) · Cleared
ClearedM2 Monitor
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 Jul 11, 2007 as substantially equivalent to K931968 (3M Health Care, Ltd., 1993) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 1993. 2 of the 17 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Jul 11, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931968 (1993). 14 later devices descend from it, 2 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
- 1 generation backK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
- This deviceK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
- Descendant · cites it directly · 10 of its ownK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · 4 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK090147 Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K072131M3 MonitorSpectrum Medical, Ltd. · 2007 · cites it directly10descendants
- K091908M3 MonitorSpectrum Medical, Ltd. · 2009 · 2 generations on5descendants
- K110957M4 MonitorSpectrum Medical, Llp · 2011 · 3 generations on4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 4 generations on3descendants
- K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio | 3M Health Care, Ltd. | 1993 | — |
| −1 | K062468 | Spectrum M2 Monitor | Spectrum Medical, Llp | 2006 | — |
| 0 (this device) | K071725 | M2 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| +1 | K072131 | M3 Monitor | Spectrum Medical, Ltd. | 2007 | — |
| +2 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| +3 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +4 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K090147 | Blood Monitoring Unit, Model Bmu 40 | Maquet Cardiopulmonary, AG | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioSummary page 1…Blood Gas Monitor Trade Name: M2 Monitor Classification Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY Predicate Devices: K931968 3M Health Care Ltd, CDI 100 Extracorporeal Hematocrit/ Oxygen Monitoring Device and K062468 Spectrum Medical Ltd, M2 Oxygen Satur… | 1993 |
| * | K062468 | Spectrum M2 MonitorSummary page 1…ardiopulmonary Bypass 21 CFR 870.4330, Product code: DRY Predicate Devices: K931968 3M Health Care Ltd, CDI 100 Extracorporeal Hematocrit/ Oxygen Monitoring Device and K062468 Spectrum Medical Ltd, M2 Oxygen Saturation Monitor. Description of Proposed Device: The Spectrum M2 Monitor consists of a 10.4… | 2006 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072131 (Spectrum Medical, Ltd., 2007) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K931968.
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. 2007, 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 M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarm levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071725: M2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071725
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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