510(k) · Cleared
Recalled · Class II · 20143M Cdi Blood Parameter Monitoring System 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Nov 6, 1997 as substantially equivalent to K890113 (Cardiovascular Devices, Inc., 1989) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1986. 2 of the 14 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 26 times.
- Decided
- Nov 6, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- DRY
- Recalls
- 26
- Predicates
- 3
Its longest line of descent runs back 1 generation to K854357 (1986). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK854357 Gem-6, with ComponentsDiamond Electro-Tech, Inc. · 1986
- This deviceK972962 3M Cdi Blood Parameter Monitoring System 5003M Company · 1997
- Descendant · cites it directly · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · 2 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK090147 Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K110957M4 MonitorSpectrum Medical, Llp · 2011 · cites it directly4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 2 generations on3descendants
- K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · cites it directly3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 3 generations on2descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854357 | Gem-6, with Components | Diamond Electro-Tech, Inc. | 1986 | — |
| 0 (this device) | K972962 | 3M Cdi Blood Parameter Monitoring System 500 | 3M Company | 1997 | — |
| +1 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +2 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| +1 | K090147 | Blood Monitoring Unit, Model Bmu 40 | Maquet Cardiopulmonary, AG | 2009 | 1 |
| +3 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 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.
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? (3)
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 |
|---|---|---|---|
| * | K890113 | The Cdi (R) System 400Summary page 1…Device Classification Name: Cardiopulmonary bypass on-line blood gas monitor and cardiopulmonary bypass in- line blood gas sensor (21 CFR 870.4330) Predicate Devices: K890113 System 400 CDI Extracorporeal Blood Gas Monitoring System K902654 System 100 CDI Hematocrit/Oxygen Saturation Monitoring System K… | 1989 |
| * | K902654 | Cdi (TM) System 100 Monitoring SystemSummary page 1…gas monitor and cardiopulmonary bypass in- line blood gas sensor (21 CFR 870.4330) Predicate Devices: K890113 System 400 CDI Extracorporeal Blood Gas Monitoring System K902654 System 100 CDI Hematocrit/Oxygen Saturation Monitoring System K854357 Mallinckrodt Gem 6 Blood Gas/Electrolyte Monitor Device De… | 1990 |
| * | K854357 | Gem-6, with ComponentsSummary page 1…FR 870.4330) Predicate Devices: K890113 System 400 CDI Extracorporeal Blood Gas Monitoring System K902654 System 100 CDI Hematocrit/Oxygen Saturation Monitoring System K854357 Mallinckrodt Gem 6 Blood Gas/Electrolyte Monitor Device Description: The 3M CDI Blood Parameter Monitoring System 500 is an AC-… | 1986 |
What descends from it? (10)
3 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 |
|---|---|---|---|---|
| May 9, 2014 | Class II | Z-1634-2014 | Release of Material/Component prior to receiving test results | There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate… |
| Feb 27, 2013 | Class II | Z-1731-2013 | Software design | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket… |
| Feb 27, 2013 | Class II | Z-1732-2013 | Software design | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. |
| Feb 27, 2013 | Class II | Z-1730-2013 | Software design | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket… |
| Feb 27, 2013 | Class II | Z-1734-2013 | Software design | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket… |
| Feb 27, 2013 | Class II | Z-1733-2013 | Software design | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket… |
| Feb 3, 2012 | Not classified | Z-1379-2012 | Labeling design | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Feb 3, 2012 | Not classified | Z-1380-2012 | Labeling design | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Feb 3, 2012 | Not classified | Z-1381-2012 | Labeling design | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Feb 3, 2012 | Not classified | Z-1378-2012 | Labeling design | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Feb 3, 2012 | Not classified | Z-1382-2012 | Labeling design | Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life. |
| Dec 6, 2011 | Not classified | Z-0672-2012 | Component change control | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been… |
| Dec 6, 2011 | Not classified | Z-0673-2012 | Component change control | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been… |
| Dec 6, 2011 | Not classified | Z-0674-2012 | Component change control | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been… |
| Dec 6, 2011 | Not classified | Z-0675-2012 | Component change control | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been… |
| Sep 23, 2011 | Not classified | Z-0142-2012 | Component design/selection | Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored. |
| Apr 21, 2011 | Not classified | Z-2679-2011 | 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-2678-2011 | 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-2682-2011 | 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-2681-2011 | 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-2680-2011 | 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-2188-2011 | Device Design | The CDI 500 monitors may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccurate values. |
| Nov 1, 2010 | Not classified | Z-2189-2011 | Device Design | The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values. |
| Nov 1, 2010 | Not classified | Z-2185-2011 | Device Design | The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH… |
| Nov 1, 2010 | Not classified | Z-2186-2011 | Device Design | The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH… |
| Nov 1, 2010 | Not classified | Z-2187-2011 | Device Design | The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values. |
The 5 latest of 26 recalls; the web page lists all.
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?
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.
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 3M CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37" C. For documentation purposes, the system 500’s integral printer provides a hard copy of displayed parameters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972962: 3M Cdi Blood Parameter Monitoring System 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972962
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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