510(k) · Cleared
Recalled · 2005Vail 1000 Enclosed Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vail Products, Inc. · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Oct 5, 1998 after a 59-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Oct 5, 1998
- Review
- 59 days
- Class
- Class II
- Product code
- FNL
- Recalls
- 1
- Predicates
- 0
The FDA summary names no predicate by number.
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 FNL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FNL device
- #1 K202964 iBed Wireless with iBed Mobilescore 2.4 · 4 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2005 | Not classified | Z-0862-05 | Device Design | Risk of patient entrapment, may result in serious injury or death. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FNL devicesFNL Bed, Ac-Powered Adjustable Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FNL
Too few FNL 510(k)s in any year since 2007 to give a median.
Recalls per year · FNL
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FNL
2,748in 2025
MAUDE reports naming product code FNL, 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 | — | 2 | 133 |
| 2008 | 0 | — | 8 | 4,482 |
| 2009 | 0 | — | 16 | 7,460 |
| 2010 | 1 | — | 6 | 12,462 |
| 2011 | 0 | — | 7 | 12,599 |
| 2012 | 0 | — | 9 | 14,612 |
| 2013 | 0 | — | 4 | 13,473 |
| 2014 | 0 | — | 4 | 5,887 |
| 2015 | 0 | — | 1 | 3,036 |
| 2016 | 0 | — | 1 | 2,075 |
| 2017 | 0 | — | 0 | 1,047 |
| 2018 | 0 | — | 2 | 1,214 |
| 2019 | 0 | — | 1 | 1,113 |
| 2020 | 0 | — | 0 | 1,106 |
| 2021 | 1 | — | 0 | 1,377 |
| 2022 | 0 | — | 2 (1) | 1,118 |
| 2023 | 0 | — | 15 | 2,185 |
| 2024 | 0 | — | 1 | 2,327 |
| 2025 | 0 | — | 0 | 2,748 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unassisted
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/K982783 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982783: Vail 1000 Enclosed Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026