FDA product code · Clinical toxicology
Anti-Müllerian Hormone Test System
5 FDA decisions since 2016. 510(k) reviews decided 2021–2025 took a median of 346 days (half between 202 and 440). 1 recall names this code; it is not Class I. The most-cited predicate is DEN150057, named by 2 later devices.
An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PQO 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 · PQO
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PQO
Too few PQO 510(k)s in any year since 2007 to give a median.
Recalls per year · PQO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQO
1in 2025
MAUDE reports naming product code PQO, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
Planning a device in PQO? 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