FDA product code · General hospital
Bed, Ac-Powered Adjustable Hospital
FDA lists FNL 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. 70 FDA decisions since 1978. 510(k) reviews decided 2021–2025 took a median of 261 days (half between 261 and 261). 110 recalls name this code, 2 of them Class I. The most-cited predicate is K963701, named by 3 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FNL 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 · 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) | — |
Planning a device in FNL? 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 880.5100.