510(k) · Cleared
ClearedCSS-Cardioplegia Safety System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Bio-Medicus, Inc. · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cleared on Apr 27, 1998 as substantially equivalent to K942582 (Sorin Biomedical, Inc., 1995) and 3 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Apr 27, 1998
- Review
- 242 days
- Class
- Class II
- Product code
- DWB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K802147 (1980). 14 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802147 | Shiley Temperature Monitor | Shiley, Inc. | 1980 | — |
| −1 | K953838 | Myocardial Protection System | Quest Medical, Inc. | 1996 | 3 |
| 0 (this device) | K973237 | CSS-Cardioplegia Safety System | Medtronic Bio-Medicus, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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 DWB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K942582 | Sorin Blood Cardioplegia ConsoleSummary page 1…eat exchanger 21 CFR 870.4390 Cardiopulmonary bypass pump tubing NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Sorin Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582) Quest Medical Inc. - Myocardial Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) B Medtroni… | 1995 |
| * | K953838 | Myocardial Protection SystemSummary page 1…ing NAME OF PREDICATE OR LEGALLY MARKETED DEVICE Sorin Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582) Quest Medical Inc. - Myocardial Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) B Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Del… | 1996 |
| * | K871131 | Sarns 9000 Heart-Lung ConsoleSummary page 1…Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582) Quest Medical Inc. - Myocardial Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) B Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755) DESCRIPTION OF DEVICE ™ The Med… | 1987 |
| * | K960755 | Cardiotherm Blood Cardioplegia SystemsSummary page 1…Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) B Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755) DESCRIPTION OF DEVICE ™ The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument… | 1996 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
How does its category compare?
All DWB devicesDWB Pump, Blood, Cardiopulmonary Bypass, Roller Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DWB
Too few DWB 510(k)s in any year since 2007 to give a median.
Recalls per year · DWB
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWB
1in 2025
MAUDE reports naming product code DWB, 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 | 0 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 11 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 0 | — | 0 | 63 |
| 2015 | 0 | — | 0 | 122 |
| 2016 | 1 | — | 0 | 318 |
| 2017 | 0 | — | 0 | 361 |
| 2018 | 0 | — | 0 | 258 |
| 2019 | 0 | — | 0 | 155 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 0 | — | 0 | 49 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medltronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous cardioplegia solution during cardiopulmonary bypass procedures.
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/K973237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973237: CSS-Cardioplegia Safety System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973237
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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