FDA product code · Ophthalmic
Gases Used Within Eye To Place Pressure On Detached Retina
4 FDA decisions since 1993. 1 recall names this code; it is not 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 LPO 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 · LPO
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · LPO
Too few LPO 510(k)s in any year since 2007 to give a median.
Recalls per year · LPO
No recall names LPO since 2007.
Adverse event reports per year · LPO
54in 2025
MAUDE reports naming product code LPO, 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 | 4 |
| 2008 | 1 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 13 |
| 2010 | 3 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 18 |
| 2022 | 2 | — | 0 | 97 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 8 | — | 0 | 9 |
| 2025 | 6 | — | 0 | 54 |
| 2026 | 11 | — | 0 | — |
Planning a device in LPO? 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