510(k) · Cleared
ClearedPosey Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. T. Posey Co. · OYS Patient Bed With Canopy/Restraints
Cleared on Apr 22, 2011 as substantially equivalent to K963701 (Nova Technology Corp., 1997) after a 114-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Apr 22, 2011
- Review
- 114 days
- Class
- Class I
- Product code
- OYS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963701 (1997). 2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963701 | Soma Safe Enclosure | Nova Technology Corp. | 1997 | — |
| 0 (this device) | K103817 | Posey Bed | J. T. Posey Co. | 2011 | — |
| +1 | K113355 | Posey Bed | J. T. Posey Co. | 2012 | — |
| +1 | K113357 | Posey Bed | J. T. Posey Co. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963701 | Soma Safe EnclosureSummary page 1…OV SUBSTANTIAL EQUIVALENCE: The proposed device is substantially equivalent to the Soma Safe Enclosure as used with an AC- powered adjustable hospital bed described in K963701 previously cleared by the FDA via the 510(k) notification process. DEVICE DESCRIPTION: The patented Posey Bed 8070 is an enclose… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OYS devicesOYS Patient Bed With Canopy/Restraints: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Posey Bed 8070 is a hospital bed, canopy, and mattress system designed to
help provide a safe, controlled environment for patients at extreme risk of injury
from a fall or unassisted bed exit. The Posey Bed 8070 is a less restrictive
alternative to physical restraints such as belts, vests, or jackets for patients at least
46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8070 is a
restraint, and must be prescribed by a licensed physician (Rx Only).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103817: Posey Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103817
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026