FDA product code · Anesthesiology
Mixer, Breathing Gases, Anesthesia Inhalation
55 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 206 days (half between 160 and 241). 1 recall names this code; it is not Class I. The most-cited predicate is K053232, named by 6 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of BZR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in BZR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report