FDA product code · Pathology
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
5 FDA decisions since 2015. 1 recall names this code; it is not Class I.
The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PLS 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 · PLS
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLS
Too few PLS 510(k)s in any year since 2007 to give a median.
Recalls per year · PLS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLS
27in 2023
MAUDE reports naming product code PLS, 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 | 1 | — | 0 | 0 |
| 2016 | 11 | — | 0 | 0 |
| 2017 | 14 | — | 0 | 2 |
| 2018 | 10 | — | 0 | 0 |
| 2019 | 10 | — | 0 | 0 |
| 2020 | 10 | — | 0 | 1 |
| 2021 | 7 | — | 0 | 3 |
| 2022 | 8 | — | 1 | 2 |
| 2023 | 8 | — | 0 | 27 |
| 2024 | 4 | — | 0 | 0 |
| 2025 | 4 | — | 0 | 0 |
| 2026 | 6 | — | 0 | — |
Planning a device in PLS? 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