510(k) · Cleared
ClearedSK Med ME202 Monitoring Mixer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sk Med · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Jan 21, 2004 after a 219-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 21, 2004
- Review
- 219 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK031860 SK Med ME202 Monitoring MixerSk Med · 2004
- Descendant · cites it directly · 0 of its ownK051192 Praxair Medical Air MixerPraxair, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051192Praxair Medical Air MixerPraxair, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031860 | SK Med ME202 Monitoring Mixer | Sk Med | 2004 | — |
| +1 | K051192 | Praxair Medical Air Mixer | Praxair, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051192 | Praxair Medical Air Mixer | 2005 | 0 |
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, K051192 (Praxair, Inc., 2005) has gone furthest, with 0 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 | — |
What is it indicated for?
The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (I to 12 LPM). The device is a prescription device and is intended for use within the hospital or institutional environment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031860: SK Med ME202 Monitoring Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031860
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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