510(k) · Cleared
Recalled · Class II · 2025CDI OneView Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corporation · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Apr 25, 2024 as substantially equivalent to K182110 (Terumo Cardiovascular Systems Corporation, 2018) after a 125-day review. Its family tree reaches back 2 generations to 2014. It has been recalled 2 times.
- Decided
- Apr 25, 2024
- Review
- 125 days
- Class
- Class II
- Product code
- DRY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K133658 (2014). No later device cites it as a predicate yet.
- Root · 2 generations backK133658 Cdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp. · 2014 · Recalled
- 1 generation backK182110 CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation · 2018
- This deviceK234065 CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K133658 | Cdi Blood Parameter Monitoring System 500 | Terumo Cardiovascular Systems Corp. | 2014 | 4 |
| −1 | K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018 | — |
| 0 (this device) | K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024 | — |
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 K202154 B-Captascore 4.7 · 3 generations · no Class I recall
- #2 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182110 | CDI Blood Parameter Monitoring System 550Summary page 4…21 CFR §870.4330 Product Code(s): DRY III. Predicate Device CDI Blood Parameter Monitoring System 550, cleared under K182110. IV. Device Description The CDI OneView Monitoring System is an AC-powered (battery back-up) microprocessor-bas… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2025 | Class II | Z-2018-2025 | Employee error | Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration… |
| Mar 3, 2025 | Class II | Z-1492-2025 | Software design | During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2024, 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 OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration: *Potential of…
Read the full statement (126 words)
The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration:
*Potential of Hydrogen (pH)
*Partial Pressure of Carbon Dioxide (pCO2)
*Partial Pressure of Oxygen (p02)
*Potassium Ion (K+)
*Oxygen Saturation (S02)
*Hematocrit (HCT)
*Hemoglobin (Hgb)
*Blood Flow Rate (0)
*Cardiac Index (CI)
*Base Excess (BE)
*Bicarbonate (HCO3-)
*Oxygen Consumption (V02)
*indexed Oxygen Consumption (VO2i)
*Oxygen Delivery (DO2)
*indexed Oxygen Delivery (DO2i)
*Cerebral Regional Oxygen Saturation (rSO2)
*Oxygen Extraction Ratio (O2ER)
*Body Surface Area (BSA)
*Shunt Sensor Temperature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234065: CDI OneView Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234065
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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