FDA product code · Clinical chemistry

Salivary Estriol Test

Name: FDA decisions, review times, recalls and adverse event reports for product code PEJ
Creator: 510(k) Report

PEJClass IIIPMA required1 decision since 19980 recalls

1 FDA decision since 1998. No recall names this code.

To detect and measure salivary estriol in pregnant women.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of PEJ 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 · PEJ

FDA has decided no PEJ device since 2007.

Median 510(k) review, days · PEJ

Too few PEJ 510(k)s in any year since 2007 to give a median.

Recalls per year · PEJ

No recall names PEJ since 2007.

Adverse event reports per year · PEJ

No MAUDE report names PEJ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — PEJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PEJ? 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

Salivary Estriol Test

What has FDA decided in PEJ lately?