510(k) · Cleared
ClearedNitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Hannifin · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Apr 22, 2021 as substantially equivalent to K760766 (Fraser Sweatman, Inc., 1976) after a 237-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Apr 22, 2021
- Review
- 237 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K760766 (1976). No later device cites it as a predicate yet.
- Root · 1 generation backK760766 Pre-Set 50/50 Nitrous Oxide/Oxygen MixerFraser Sweatman, Inc. · 1976
- This deviceK202480 Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760766 | Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer | Fraser Sweatman, Inc. | 1976 | — |
| 0 (this device) | K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | 2021 | — |
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 |
|---|---|---|---|
| * | K760766 | Pre-Set 50/50 Nitrous Oxide/Oxygen MixerSummary page 4…Product Code: BZR Device Class: Class II 5.3. Predicate Device Nitronox Pre-Set 50/50 Nitrous Oxide/Oxygen Gas Mixer (K760766) 5.4. Device Description The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous… | 1976 |
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. 2021, 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 Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202480: Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202480
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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