510(k) · Cleared
Recalled · Class III · 2015Cdi (TM) H/S Cuvette, Modification
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 Jan 15, 1992 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 15, 1992
- Review
- 57 days
- Class
- Class II
- Product code
- DRY
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK915265 Cdi (TM) H/S Cuvette, Modification3M Company · 1992
- Descendant · cites it directly · 0 of its ownK082321 Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp. · 2009
Most influential descendants
Showing 1 of 1 · See all- K082321Terumo Rocsafe Hybrid Perfusion SystemTerumo Cardiovascular Systems Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915265 | Cdi (TM) H/S Cuvette, Modification | 3M Company | 1992 | — |
| +1 | K082321 | Terumo Rocsafe Hybrid Perfusion System | Terumo Cardiovascular Systems Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K082321 | Terumo Rocsafe Hybrid Perfusion System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2015 | Class III | Z-0001-2017 | Other | Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082321 (Terumo Cardiovascular Systems Corp., 2009) 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.
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 | — |
https://510kreport.com/device/K915265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915265: Cdi (TM) H/S Cuvette, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915265
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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