510(k) · Cleared
ClearedStockert S5 System and Gas Blender and Sorin C5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Deutschland GmbH · DTX Gas Control Unit, Cardiopulmonary Bypass
Cleared on Dec 9, 2010 as substantially equivalent to K023745 (Sechrist Industries, Inc., 2003) after a 239-day review. Its family tree reaches back 3 generations to 1980. 3 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 239 days
- Class
- Class II
- Product code
- DTX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K802226 (1980). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK802226 Sechrist Series 3500 Air-Oxygen MixerSechrist Industries, Inc. · 1980
- 2 generations backK992503 Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesSechrist Industries, Inc. · 1999
- 1 generation backK023745 Sechrist Air/Oxygen Mixer, Model 3500 CP-GSechrist Industries, Inc. · 2003
- This deviceK101046 Stockert S5 System and Gas Blender and Sorin C5 SystemSorin Group Deutschland GmbH · 2010
- Descendant · cites it directly · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802226 | Sechrist Series 3500 Air-Oxygen Mixer | Sechrist Industries, Inc. | 1980 | — |
| −2 | K992503 | Sechrist Air-Oxygen Mixer, 3500/3500HL Series | Sechrist Industries, Inc. | 1999 | — |
| −1 | K023745 | Sechrist Air/Oxygen Mixer, Model 3500 CP-G | Sechrist Industries, Inc. | 2003 | — |
| 0 (this device) | K101046 | Stockert S5 System and Gas Blender and Sorin C5 System | Sorin Group Deutschland GmbH | 2010 | — |
| +1 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
| +3 | K210669 | Quantum Mini Ventilation Module | Spectrum Medical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 DTX? 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 DTX device
- #1 K202733 Quantum Ventilation Modulescore 5.3 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K023745 | Sechrist Air/Oxygen Mixer, Model 3500 CP-GSummary page 1…unit, cardiopulmonary bypass (21 CFR 870.4300; Product Code: DTX) 3. PREDICATE DEVICES Sechrist Model 3500CP-G Air/Oxygen Mixer (K023745; Product Code: DTX; 21 CFR 870.4300) 4. DEVICE DESCRIPTION Physical Description The Stockedt Gas Blender Base… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181942 | Quantum Ventilation Module | 2018 | 2 |
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 30 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K181942 (Spectrum Medical, Ltd., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DTX devicesDTX Gas Control Unit, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DTX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DTX
Too few DTX 510(k)s in any year since 2007 to give a median.
Recalls per year · DTX
No recall names DTX since 2007.
Adverse event reports per year · DTX
127in 2025
MAUDE reports naming product code DTX, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 48 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 1 | — | 0 | 63 |
| 2021 | 1 | — | 0 | 77 |
| 2022 | 0 | — | 0 | 69 |
| 2023 | 0 | — | 0 | 69 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 127 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stöckert Gas Blenders (2L, 5L, and 10L) are intended to enable
qualified personnel to set monitor and control gas flows of medical grade
gases (air/O2/CO2) during cardiopulmonary bypass. The Stockert Gas
Blenders are used as components of or optional accessories to the
Stöckert S5 System (or any compatible Sorin system using the S5
firmware versions of 3.0 or greater) for periods of six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101046: Stockert S5 System and Gas Blender and Sorin C5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101046
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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