FDA product code · General hospital
Patient Bed With Canopy/Restraints
FDA lists OYS 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. 3 FDA decisions since 2011. 1 recall names this code; it is Class I. The most-cited predicate is K103817, named by 2 later devices.
Enclosed bed canopy system used as passive restraint.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OYS 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 · OYS
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OYS
Too few OYS 510(k)s in any year since 2007 to give a median.
Recalls per year · OYS
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OYS
86in 2025
MAUDE reports naming product code OYS, 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 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 80 |
| 2014 | 0 | — | 0 | 53 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 (1) | 28 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 0 | 86 |
| 2026 | 0 | — | 0 | — |
Planning a device in OYS? 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 880.6760.