510(k) · Cleared
ClearedSoma 900 Transport Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Technologies, Inc. · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Jul 10, 1997 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 10, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- FNL
- 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 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?
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 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 Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal injury to the patient and staff.
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/K971546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971546: Soma 900 Transport Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971546
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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