FDA product code · Microbiology
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
2 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 578 days (half between 577 and 579). No recall names this code. The most-cited predicate is K200839, named by 2 later devices.
Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QQY 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 · QQY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QQY
Too few QQY 510(k)s in any year since 2007 to give a median.
Recalls per year · QQY
No recall names QQY since 2007.
Adverse event reports per year · QQY
No MAUDE report names QQY since 2007.
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 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QQY? 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 866.2190.