510(k) · Cleared
ClearedStockertir Purge Control (Apc) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stockert Instrumente GmbH · DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Cleared on Jul 2, 2004 as substantially equivalent to K955152 (Stoeckert Instrumente, 1996) after a 22-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jul 2, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- DTW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955152 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955152 Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont.…Stoeckert Instrumente · 1996
- This deviceK041558 Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004
- Descendant · cites it directly · 0 of its ownK103469 Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH · 2011
Most influential descendants
Showing 1 of 1 · See all- K103469Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer | Stoeckert Instrumente | 1996 | — |
| 0 (this device) | K041558 | Stockertir Purge Control (Apc) System | Stockert Instrumente GmbH | 2004 | — |
| +1 | K103469 | Stockert Air Purge Control System Model 23-45-05 | Sorin Group Deutschland GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 DTW? 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 |
|---|---|---|---|
| * | K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., TimerSummary page 1…bble detector and sensor Classification Name: Cardiopulmonary bypass bubble detector 3. PREDICATE DEVICE St6ckert S3 Level Control and Bubble Detector (K955152) 4. DEVICE DESCRIPTION The St6ckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble D… | 1996 |
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 |
|---|---|---|---|
| K103469 | Stockert Air Purge Control System Model 23-45-05 | 2011 | 0 |
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.
- Of its descendants, K103469 (Sorin Group Deutschland GmbH, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTW devicesDTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTW
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTW
Too few DTW 510(k)s in any year since 2007 to give a median.
Recalls per year · DTW
5in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTW
4in 2024
MAUDE reports naming product code DTW, 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 | — | 5 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 47 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S3 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041558: Stockertir Purge Control (Apc) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041558
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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