510(k) · Cleared
Recalled · 2011Cdi (TM) System 100 Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Ltd. · DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Cleared on Nov 5, 1990 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 15 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 5, 1990
- Review
- 143 days
- Class
- Class II
- Product code
- DTY
- Recalls
- 5
- Predicates
- 0
14 later devices descend from it, 3 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- This deviceK902654 Cdi (TM) System 100 Monitoring System3M Health Care, Ltd. · 1990
- Descendant · cites it directly · 10 of its ownK972962 3M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · Recalled
- Descendant · 2 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · 3 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
- Descendant · 4 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
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- K9729623M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · cites it directly10descendants
- K110957M4 MonitorSpectrum Medical, Llp · 2011 · 2 generations on4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 3 generations on3descendants
- K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · 2 generations on3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902654 | Cdi (TM) System 100 Monitoring System | 3M Health Care, Ltd. | 1990 | — |
| +1 | K972962 | 3M Cdi Blood Parameter Monitoring System 500 | 3M Company | 1997 | 26 |
| +2 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +3 | 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 |
| +4 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2011 | Not classified | Z-2610-2011 | Device Design | Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System… |
| Apr 21, 2011 | Not classified | Z-2684-2011 | Device Design | Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would… |
| Apr 21, 2011 | Not classified | Z-2683-2011 | Device Design | Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would… |
| Nov 1, 2010 | Not classified | Z-1943-2011 | Device Design | Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate. |
| Nov 1, 2010 | Not classified | Z-1944-2011 | Device Design | Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate. |
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?
- Of its descendants, K972962 (3M Company, 1997) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DTY devicesDTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTY
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DTY
Too few DTY 510(k)s in any year since 2007 to give a median.
Recalls per year · DTY
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTY
3in 2015
MAUDE reports naming product code DTY, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 2 | 130 |
| 2011 | 0 | — | 0 | 158 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K902654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902654: Cdi (TM) System 100 Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902654
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026