FDA product code · General hospital
Bariatric Bed
FDA lists OSI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 1 recall names this code; it is not Class I.
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OSI 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 · OSI
FDA has decided no OSI device since 2007.
Median 510(k) review, days · OSI
Too few OSI 510(k)s in any year since 2007 to give a median.
Recalls per year · OSI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSI
166in 2025
MAUDE reports naming product code OSI, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 86 |
| 2014 | 0 | — | 0 | 101 |
| 2015 | 0 | — | 0 | 124 |
| 2016 | 0 | — | 0 | 72 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 176 |
| 2024 | 0 | — | 0 | 219 |
| 2025 | 0 | — | 1 | 166 |
| 2026 | 0 | — | 0 | — |
Planning a device in OSI? 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) ReportRelated product codes
Other codes under 21 CFR 880.5100.