FDA product code · Clinical chemistry
Alkaline Picrate, Colorimetry, Creatinine
159 FDA decisions since 1977. 510(k) reviews decided 2021–2025 took a median of 318 days (half between 199 and 520). 12 recalls name this code, 0 of them Class I. The most-cited predicate is K951595, named by 32 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of CGX 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 · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
Planning a device in CGX? 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 862.1225.