510(k) · Cleared
ClearedSechrist Air/Oxygen Mixer, Model 3500 CP-G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sechrist Industries, Inc. · DTX Gas Control Unit, Cardiopulmonary Bypass
Cleared on Jan 17, 2003 as substantially equivalent to K802226 (Sechrist Industries, Inc., 1980) and 4 other predicates after a 71-day review. Its family tree reaches back 2 generations to 1980. 4 later devices descend from it.
- Decided
- Jan 17, 2003
- Review
- 71 days
- Class
- Class II
- Product code
- DTX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K802226 (1980). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK802226 Sechrist Series 3500 Air-Oxygen MixerSechrist Industries, Inc. · 1980
- 1 generation backK992503 Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesSechrist Industries, Inc. · 1999
- This deviceK023745 Sechrist Air/Oxygen Mixer, Model 3500 CP-GSechrist Industries, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK101046 Stockert S5 System and Gas Blender and Sorin C5 SystemSorin Group Deutschland GmbH · 2010
- Descendant · 2 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K101046Stockert S5 System and Gas Blender and Sorin C5 SystemSorin Group Deutschland GmbH · 2010 · cites it directly3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 2 generations on2descendants
- K202733Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020 · 3 generations on1descendant
- K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802226 | Sechrist Series 3500 Air-Oxygen Mixer | Sechrist Industries, Inc. | 1980 | — |
| −1 | K992503 | Sechrist Air-Oxygen Mixer, 3500/3500HL Series | Sechrist Industries, Inc. | 1999 | — |
| 0 (this device) | K023745 | Sechrist Air/Oxygen Mixer, Model 3500 CP-G | Sechrist Industries, Inc. | 2003 | — |
| +1 | K101046 | Stockert S5 System and Gas Blender and Sorin C5 System | Sorin Group Deutschland GmbH | 2010 | — |
| +2 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +3 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
| +4 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K802226 | Sechrist Series 3500 Air-Oxygen MixerSummary page 1…ssification Name: Breathing Gas Mixer Common Name: Gas Mixer Proprietary Name: Sechrist 3500CP-G Aidoxygen Mixer Devices to which Equivalence is Claimed: K802226 Sechrist Adoxygen Mixer K992503 Sechrist Aidoxygen Mixer K84 1789 S… | 1980 |
| * | K992503 | Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesSummary page 1…Mixer Proprietary Name: Sechrist 3500CP-G Aidoxygen Mixer Devices to which Equivalence is Claimed: K802226 Sechrist Adoxygen Mixer K992503 Sechrist Aidoxygen Mixer K84 1789 Sechrist Aidoxygen Mixer (Shiley, Inc.)… | 1999 |
| * | K841789 | Sechrist Air-Oxygen Mixer & AncillarySummary page 1…es to which Equivalence is Claimed: K802226 Sechrist Adoxygen Mixer K992503 Sechrist Aidoxygen Mixer K84 1789 Sechrist Aidoxygen Mixer (Shiley, Inc.) K863902 Modified Sarns Membrane Oxygenator (Sarns,… | 1984 |
| * | K863902 | Modified Sarns Membrane OxygenatorSummary page 1…K992503 Sechrist Aidoxygen Mixer K84 1789 Sechrist Aidoxygen Mixer (Shiley, Inc.) K863902 Modified Sarns Membrane Oxygenator (Sarns, Inc./3M) K90125… | 1986 |
| * | K901253 | (PBS) Portable Bypass System, Model 1000Summary page 1…, Inc.) K863902 Modified Sarns Membrane Oxygenator (Sarns, Inc./3M) K901253 (PBS) Portable Bypass System, Model 1000 Bio-Medicus Contact: Greg… | 1990 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101046 | Stockert S5 System and Gas Blender and Sorin C5 System | 2010 | 3 |
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 23 years and passes through 1 company; a new generation was cleared every 18.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K101046 (Sorin Group Deutschland GmbH, 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K802226.
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.
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 intended use of the Sechrist Model 3500CP-G Aidoxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023745: Sechrist Air/Oxygen Mixer, Model 3500 CP-G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023745
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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