510(k) · Cleared
ClearedRest Mattress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rest Mattress · FNM Mattress, Air Flotation, Alternating Pressure
Cleared on Jul 18, 1997 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 18, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- FNM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FNM? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All FNM devicesFNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNM
FDA has decided no FNM device since 2007.
Median 510(k) review, days · FNM
Too few FNM 510(k)s in any year since 2007 to give a median.
Recalls per year · FNM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FNM
128in 2025
MAUDE reports naming product code FNM, 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 | 33 |
| 2008 | 0 | — | 4 | 35 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 1 | 56 |
| 2011 | 0 | — | 0 | 291 |
| 2012 | 0 | — | 0 | 303 |
| 2013 | 0 | — | 0 | 223 |
| 2014 | 0 | — | 0 | 80 |
| 2015 | 0 | — | 0 | 80 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 0 | — | 0 | 115 |
| 2019 | 0 | — | 0 | 101 |
| 2020 | 0 | — | 0 | 58 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 197 |
| 2024 | 0 | — | 0 | 254 |
| 2025 | 0 | — | 1 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971568: Rest Mattress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971568
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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