510(k) · Cleared
Recalled · Class II · 2018Cdi Blood Parameter Monitoring System 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Jul 25, 2014 after a 240-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 25, 2014
- Review
- 240 days
- Class
- Class II
- Product code
- DRY
- Recalls
- 4
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceK133658 Cdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp. · 2014
- Descendant · cites it directly · 1 of its ownK182110 CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK234065 CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation · 2024 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K133658 | Cdi Blood Parameter Monitoring System 500 | Terumo Cardiovascular Systems Corp. | 2014 | — |
| +1 | K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018 | — |
| +2 | K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K033926 | FDA’s K033926 is Hourglass Vertebral Body Spacer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
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 |
|---|---|---|---|
| K182110 | CDI Blood Parameter Monitoring System 550 | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2018 | Class II | Z-2750-2018 | Vendor change control | H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not… |
| Jun 26, 2018 | Class II | Z-2751-2018 | Vendor change control | H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not… |
| Mar 14, 2016 | Class II | Z-1250-2016 | Nonconforming Material/Component | Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the… |
| Aug 7, 2015 | Class II | Z-2742-2015 | Software design | Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182110 (Terumo Cardiovascular Systems Corporation, 2018) has gone furthest, with 1 descendant 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. 2014, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K133658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133658: 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/K133658
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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