510(k) · Cleared
ClearedS3 Mast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stoeckert Instrumente · DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Cleared on Feb 27, 1998 as substantially equivalent to K955038 (Stoeckert Instrumente, 1996) after a 249-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 27, 1998
- Review
- 249 days
- Class
- Class II
- Product code
- DWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955038 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955038 Stockert S3 Double Head Pump ModuleStoeckert Instrumente · 1996
- This deviceK972321 S3 Mast PumpStoeckert Instrumente · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955038 | Stockert S3 Double Head Pump Module | Stoeckert Instrumente | 1996 | — |
| 0 (this device) | K972321 | S3 Mast Pump | Stoeckert Instrumente | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K955038 | Stockert S3 Double Head Pump ModuleSummary page 1…e to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3- Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for-the Mast Pump, the pump heads are mounted:on the mast of a… | 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?
- Its one ancestor has no recall.
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 Stockert S3 Mast Pump is a modular component of the Stickert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of
cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.
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/K972321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972321: S3 Mast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972321
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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