FDA product code · Pathology
Processor, Cervical Cytology Slide, Automated
3 FDA decisions since 1996. 17 recalls name this code, 0 of them Class I. The most-cited predicate is P950039, named by 1 later device.
It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MKQ 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 · MKQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKQ
Too few MKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MKQ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKQ
38in 2025
MAUDE reports naming product code MKQ, 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 | 5 | — | 0 | 7 |
| 2008 | 5 | — | 1 | 8 |
| 2009 | 4 | — | 0 | 6 |
| 2010 | 5 | — | 0 | 18 |
| 2011 | 2 | — | 15 | 19 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 7 | — | 0 | 16 |
| 2015 | 2 | — | 0 | 22 |
| 2016 | 6 | — | 1 | 28 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 3 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 1 | — | 0 | 56 |
| 2025 | 1 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
Planning a device in MKQ? 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