510(k) · Cleared
ClearedStockert Air Purge Control System Model 23-45-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · KRL Detector, Bubble, Cardiopulmonary Bypass
Cleared on Jan 18, 2011 as substantially equivalent to K091007 (Sorin Group Deutschland GmbH, 2009) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jan 18, 2011
- Review
- 55 days
- Class
- Class II
- Product code
- KRL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955152 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK955152 Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont.…Stoeckert Instrumente · 1996
- 1 generation backK041558 Stockertir Purge Control (Apc) SystemStockert Instrumente GmbH · 2004
- This deviceK103469 Stockert Air Purge Control System Model 23-45-05Sorin Group Deutschland GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer | Stoeckert Instrumente | 1996 | — |
| −1 | K041558 | Stockertir Purge Control (Apc) System | Stockert Instrumente GmbH | 2004 | — |
| 0 (this device) | K103469 | Stockert Air Purge Control System Model 23-45-05 | Sorin Group Deutschland GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 KRL? 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? (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 |
|---|---|---|---|
| * | K091007 | Air Purge Control System for S5 System Model 23-45-05Summary page 1…870.4205; Product Code: KRL) 3. PREDICATE DEVICES * St6ckert Air Purge Control (APC) System for S5 System Model 23-45-05 (K09 1007) * St6ckert Air Purge Control (APC) System (K041558) 4. DEVICE DESCRIPTION * Physical description The St… | 2009 |
| * | K041558 | Stockertir Purge Control (Apc) SystemSummary page 1…PREDICATE DEVICES * St6ckert Air Purge Control (APC) System for S5 System Model 23-45-05 (K09 1007) * St6ckert Air Purge Control (APC) System (K041558) 4. DEVICE DESCRIPTION * Physical description The St6ckert APC System consists of the APC sensor module (Catalo… | 2004 |
| † | K091008 | Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55 | 2009 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KRL devicesKRL Detector, Bubble, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KRL
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRL
Too few KRL 510(k)s in any year since 2007 to give a median.
Recalls per year · KRL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRL
4in 2024
MAUDE reports naming product code KRL, 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 | 1 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stbckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the SynergyTM/ECC. OTM System tubing circuit. The Synergy TM/ECCO TM shall only be used in conjunction with the Stdckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCIP Plus System.
The Stbckert S5 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103469: Stockert Air Purge Control System Model 23-45-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103469
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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