FDA product code · Pathology
Immunocytochemistry Assay, P16/Ki-67
1 FDA decision since 2020. No recall names this code.
The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QKF 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 · QKF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKF
Too few QKF 510(k)s in any year since 2007 to give a median.
Recalls per year · QKF
No recall names QKF since 2007.
Adverse event reports per year · QKF
1in 2024
MAUDE reports naming product code QKF, 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | — | 0 | 0 |
| 2023 | 3 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 3 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QKF? 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 864.1860.