FDA product code · Radiology
Shield, Protective, Personnel
FDA lists KPY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 25 FDA decisions since 1978. 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 KPY 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 · KPY
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KPY
Too few KPY 510(k)s in any year since 2007 to give a median.
Recalls per year · KPY
No recall names KPY since 2007.
Adverse event reports per year · KPY
1in 2023
MAUDE reports naming product code KPY, 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 | 4 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in KPY? 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 892.6500.