510(k) · Cleared
ClearedSedara Gas Mixer, Sedara Scavenger Model: 03, 04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linde Healthcare AB · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Oct 20, 2011 as substantially equivalent to K883833 (Matrix Medica, Inc., 1989) and 1 other predicate after a 531-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Oct 20, 2011
- Review
- 531 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790333 (1979). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790333 | Nad Scavenging Relief Valve | Draeger Medical, Inc. | 1979 | — |
| −1 | K080039 | Passive Waste Gas Scavenger, Model 14600 | G. Dundas Co.,Inc. | 2008 | — |
| 0 (this device) | K101286 | Sedara Gas Mixer, Sedara Scavenger Model: 03, 04 | Linde Healthcare AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 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? (2)
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 |
|---|---|---|---|
| * | K883833 | Nitronox (R), First Response Nitronox (TM)Summary page 1…dicate Device Identification Legally marketed devices to which equivalence isbeing claimed 510(k) # Nitronox First Response, Matrx K883833 Passive Waste Scavenger, GDundas Company K080039 Intended Use &iindication for Use: The SEDARA T m Gas… | 1989 |
| * | K080039 | Passive Waste Gas Scavenger, Model 14600Summary page 1…e isbeing claimed 510(k) # Nitronox First Response, Matrx K883833 Passive Waste Scavenger, GDundas Company K080039 Intended Use &iindication for Use: The SEDARA T m Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (P4 2… | 2008 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 29.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K883833.
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. 2011, this device’s year, is highlighted.
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 SEDARA™ Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (N2O) and oxygen (O2), in a ratio of 1:1, at a fixed concentration of 50%/50% (V/V), to spontaneously breathing patients of at least 15 kg body weight and four years of age, who have been examined by the attending physician prior to SEDARA™ System use and are under the continuous supervision of a healthcare professional in a clinical facility, such as a hospital, a free-standing ambulatory surgical center, or an outpatient clinic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101286 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101286: Sedara Gas Mixer, Sedara Scavenger Model: 03, 04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101286
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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