510(k) · Cleared
ClearedS3 Cardioplegia Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stoeckert Instrumente · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Jan 10, 1997 after a 207-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 10, 1997
- Review
- 207 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DTR? 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 DTR device
- #1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 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 |
|---|---|---|---|
| * | — | Stockert CAPS Cardioplegia Control unit Named without a submission number |
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.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTR
Too few DTR 510(k)s in any year since 2007 to give a median.
Recalls per year · DTR
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTR
44in 2025
MAUDE reports naming product code DTR, 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 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 24 | 43 |
| 2011 | 0 | — | 3 | 67 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 0 | — | 1 | 96 |
| 2016 | 0 | — | 0 | 60 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 75 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 2 | — | 0 | 23 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 44 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure.
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/K962320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962320: S3 Cardioplegia Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962320
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026