510(k) · Cleared
ClearedSechrist Series 3500 Air-Oxygen Mixer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sechrist Industries, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Sep 26, 1980 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 26, 1980
- Review
- 14 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK802226 Sechrist Series 3500 Air-Oxygen MixerSechrist Industries, Inc. · 1980
- Descendant · cites it directly · 5 of its ownK992503 Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesSechrist Industries, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK023745 Sechrist Air/Oxygen Mixer, Model 3500 CP-GSechrist Industries, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK101046 Stockert S5 System and Gas Blender and Sorin C5 SystemSorin Group Deutschland GmbH · 2010
- Descendant · 3 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992503Sechrist Air-Oxygen Mixer, 3500/3500HL SeriesSechrist Industries, Inc. · 1999 · cites it directly5descendants
- K023745Sechrist Air/Oxygen Mixer, Model 3500 CP-GSechrist Industries, Inc. · 2003 · cites it directly4descendants
- K101046Stockert S5 System and Gas Blender and Sorin C5 SystemSorin Group Deutschland GmbH · 2010 · 2 generations on3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 3 generations on2descendants
- K202733Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802226 | Sechrist Series 3500 Air-Oxygen Mixer | Sechrist Industries, Inc. | 1980 | — |
| +1 | 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 | — |
| +2 | K101046 | Stockert S5 System and Gas Blender and Sorin C5 System | Sorin Group Deutschland GmbH | 2010 | — |
| +3 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +4 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZR? 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 BZR device
- #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K992503 (Sechrist Industries, Inc., 1999) has gone furthest, with 5 descendants of its own.
How does its category compare?
All BZR devicesBZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZR
203in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZR
No recall names BZR since 2007.
Adverse event reports per year · BZR
13in 2025
MAUDE reports naming product code BZR, 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 | 15 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 2 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 1 | — | 0 | 39 |
| 2016 | 1 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 4 | 203 | 0 | 19 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K802226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K802226: Sechrist Series 3500 Air-Oxygen Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K802226
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026