FDA product code · Clinical chemistry
Titrimetric With Edta And Indicator, Calcium
3 FDA decisions since 1978. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of CHW 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 · CHW
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CHW
Too few CHW 510(k)s in any year since 2007 to give a median.
Recalls per year · CHW
No recall names CHW since 2007.
Adverse event reports per year · CHW
22in 2025
MAUDE reports naming product code CHW, 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
Planning a device in CHW? 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 862.1145.