510(k) · Cleared
ClearedPraxair Medical Air Mixer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxair, Inc. · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Sep 6, 2005 as substantially equivalent to K031860 (Sk Med, 2004) after a 119-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 6, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031860 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK031860 SK Med ME202 Monitoring MixerSk Med · 2004
- This deviceK051192 Praxair Medical Air MixerPraxair, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031860 | SK Med ME202 Monitoring Mixer | Sk Med | 2004 | — |
| 0 (this device) | K051192 | Praxair Medical Air Mixer | Praxair, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K031860 | SK Med ME202 Monitoring MixerSummary page 1…tem COMMON NAME Mixer, Breathing Gases, Anesthesia Inhalation PRODUCT CLASSIFICATION Class II, 21 C.F.R. § 868.5330 Product Code: BZR PREDICATE DEVICE K031860 M202 Monitoring Mixer DESCRiPTION mixes The PR… | 2004 |
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?
- Its one ancestor has no recall.
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 Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician.
The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051192: Praxair Medical Air Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051192
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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