510(k) · Cleared
ClearedSechrist Air-Oxygen Mixer, 3500/3500HL Series
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 Aug 10, 1999 as substantially equivalent to K802226 (Sechrist Industries, Inc., 1980) after a 14-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.
- Decided
- Aug 10, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802226 (1980). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK802226 Sechrist Series 3500 Air-Oxygen MixerSechrist Industries, Inc. · 1980
- This deviceK992503 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
- Descendant · 5 generations on · 0 of its ownK210669 Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- 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
- K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802226 | Sechrist Series 3500 Air-Oxygen Mixer | Sechrist Industries, Inc. | 1980 | — |
| 0 (this device) | 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 | — |
| +5 | K210669 | Quantum Mini Ventilation Module | Spectrum Medical, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K802226 | Sechrist Series 3500 Air-Oxygen MixerSummary page 1…ication Name: Breathing gas mixer Common Name: Gas Mixer Proprietary Name: Sechrist Air-Oxygen Mixer Devices to which Equivalence is Claimed: Sechrist Air-Oxygen Mixer K802226 Contact: Greg Godfrey, Vice President Quality Assurance & Regulatory Affairs 4225 E. La Palma Avenue Anaheim, CA 92807 Phone: (7… | 1980 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023745 | Sechrist Air/Oxygen Mixer, Model 3500 CP-G | 2003 | 4 |
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?
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 | — |
What is it indicated for?
The purpose of the device 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 equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992503: Sechrist Air-Oxygen Mixer, 3500/3500HL Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992503
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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