FDA product code · Clinical toxicology

Prognostic Test For Development Or Progression Of Preeclampsia

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

QWHClass II21 CFR 862.1602510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 261 days (half between 261 and 261). No recall names this code. The most-cited predicate is DEN220027, named by 1 later device.

A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.

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 toxicology panel

Twenty years of QWH 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 · QWH

1in 2025

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QWH

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

Recalls per year · QWH

No recall names QWH since 2007.

Adverse event reports per year · QWH

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code QWH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	1	—	2
2026	0	—	—

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

Planning a device in QWH? 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

Prognostic Test For Development Or Progression Of Preeclampsia

Which predicates do QWH devices cite most?

Which QWH devices have the deepest lineage?

What has FDA decided in QWH lately?