510(k) · Cleared
ClearedCDI Blood Parameter Monitoring System 550
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 Nov 2, 2018 as substantially equivalent to K133658 (Terumo Cardiovascular Systems Corp., 2014) after an 88-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.
- Decided
- Nov 2, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133658 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK133658 Cdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp. · 2014 · Recalled
- This deviceK182110 CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems Corporation · 2018
- Descendant · cites it directly · 0 of its ownK234065 CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K133658 | Cdi Blood Parameter Monitoring System 500 | Terumo Cardiovascular Systems Corp. | 2014 | 4 |
| 0 (this device) | K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018 | — |
| +1 | K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133658 | Cdi Blood Parameter Monitoring System 500Summary page 4…rameter Monitoring System 550 is substantially equivalent in function and intended use to the CDI Blood Parameter Monitoring System 500 cleared in Premarket Notification K133658. 3 August 2018 Page 1 of 6 Terumo Cardiovasc… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234065 | CDI OneView Monitoring System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K234065 (Terumo Cardiovascular Systems Corporation, 2024) has gone furthest, with 0 descendants 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. 2018, 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 550 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, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182110: CDI Blood Parameter Monitoring System 550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182110
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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