FDA product code · General hospital
Chair, Examination And Treatment
FDA lists FRK 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. 4 FDA decisions since 1979. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of FRK 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 · FRK
FDA has decided no FRK device since 2007.
Median 510(k) review, days · FRK
Too few FRK 510(k)s in any year since 2007 to give a median.
Recalls per year · FRK
No recall names FRK since 2007.
Adverse event reports per year · FRK
12in 2025
MAUDE reports naming product code FRK, 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 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 279 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 0 | 71 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
Planning a device in FRK? 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 880.6140.