FDA product code · Pathology
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
1 FDA decision since 2015. No recall names this code.
The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PKW 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 · PKW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKW
Too few PKW 510(k)s in any year since 2007 to give a median.
Recalls per year · PKW
No recall names PKW since 2007.
Adverse event reports per year · PKW
1in 2024
MAUDE reports naming product code PKW, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 4 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in PKW? 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) Report