FDA product code · Anesthesiology
Ventilator, High Frequency
4 FDA decisions since 1988. 7 recalls name this code, 1 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LSZ 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 · LSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LSZ
Too few LSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LSZ
2in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LSZ
72in 2025
MAUDE reports naming product code LSZ, 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 | 1 | — | 0 | 35 |
| 2008 | 0 | — | 0 | 58 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 2 | 35 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 1 | — | 1 (1) | 47 |
| 2013 | 3 | — | 0 | 34 |
| 2014 | 2 | — | 0 | 29 |
| 2015 | 4 | — | 0 | 195 |
| 2016 | 3 | — | 0 | 394 |
| 2017 | 3 | — | 0 | 140 |
| 2018 | 3 | — | 0 | 88 |
| 2019 | 3 | — | 0 | 88 |
| 2020 | 2 | — | 0 | 154 |
| 2021 | 3 | — | 0 | 224 |
| 2022 | 2 | — | 1 | 220 |
| 2023 | 4 | — | 2 | 186 |
| 2024 | 4 | — | 0 | 110 |
| 2025 | 2 | — | 0 | 72 |
| 2026 | 2 | — | 0 | — |
Planning a device in LSZ? 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