FDA product code · Clinical chemistry
Prognostic Test For Assessment Of Chronic Kidney Disease Progression
1 FDA decision since 2023. 3 recalls name this code, 0 of them Class I.
A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QWZ 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 · QWZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWZ
Too few QWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QWZ
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QWZ
No MAUDE report names QWZ 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QWZ? 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