FDA product code · Anesthesiology
Set, Tubing And Support, Ventilator (W Harness)
FDA lists BZO as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 88 FDA decisions since 1976. 6 recalls name this code, 3 of them Class I. The most-cited predicate is K945740, named by 2 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 BZO 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 · BZO
FDA has decided no BZO device since 2007.
Median 510(k) review, days · BZO
Too few BZO 510(k)s in any year since 2007 to give a median.
Recalls per year · BZO
2so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · BZO
70in 2025
MAUDE reports naming product code BZO, 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 | 43 |
| 2008 | 0 | — | 0 | 41 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 0 | — | 0 | 140 |
| 2011 | 0 | — | 0 | 186 |
| 2012 | 0 | — | 1 (1) | 99 |
| 2013 | 0 | — | 0 | 122 |
| 2014 | 0 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 46 |
| 2018 | 0 | — | 0 | 26 |
| 2019 | 0 | — | 0 | 33 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 37 |
| 2024 | 0 | — | 0 | 45 |
| 2025 | 0 | — | 1 (1) | 70 |
| 2026 | 0 | — | 2 (1) | — |
Planning a device in BZO? 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