510(k) · Cleared
Cleared3M Cdi H/S Cuvettes with Heparon Treatment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Dec 8, 1997 as substantially equivalent to K902654 (3M Health Care, Ltd., 1990) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Dec 8, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902654 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902654 Cdi (TM) System 100 Monitoring System3M Health Care, Ltd. · 1990 · Recalled
- This deviceK973472 3M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902654 | Cdi (TM) System 100 Monitoring System | 3M Health Care, Ltd. | 1990 | 5 |
| 0 (this device) | K973472 | 3M Cdi H/S Cuvettes with Heparon Treatment | 3M Healthcare | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (2)
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 |
|---|---|---|---|
| * | K902654 | Cdi (TM) System 100 Monitoring SystemSummary page 1…blood gas monitor and cardiopulmonary bypass in line blood gas sensor (21 CFR 870.4330) Predicate Devices: Product 510(k) Number Clearance Date CDI 100 Extracorporeal K902654 11/5/90 Hematocrit/Oxygen Saturation Monitoring System PDR Thoracic Catheter, Atrium Medical | K912645 9/13/91 (heparin coating… | 1990 |
| * | K912645 | Atriums PDR Thoracic CatheterSummary page 1…es: Product 510(k) Number Clearance Date CDI 100 Extracorporeal K902654 11/5/90 Hematocrit/Oxygen Saturation Monitoring System PDR Thoracic Catheter, Atrium Medical | K912645 9/13/91 (heparin coating only) Device Description: The 3M CDI H/S Cuvettes with Heparon Treatment are sterile, single-use medica… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K902654.
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?
These cuvettes are to be used with the CDI 100 Extracorporeal Hematocrit’Oxygen Saturation Monitoring System, which is intended for use during cardiopulmonary bypass procedures when continuous monitoring og blood hematocrit, hemoglobin, and oxygen saturation is desired.
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/K973472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973472: 3M Cdi H/S Cuvettes with Heparon Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973472
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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