FDA product code · Obstetrics and gynecology

System, Water, Reproduction, Assisted, And Purification

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

MTWClass II21 CFR 884.6170510(k) required2 decisions since 20000 recalls

2 FDA decisions since 2000. No recall names this code.

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, obstetrics and gynecology panel

Twenty years of MTW 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 · MTW

FDA has decided no MTW device since 2007.

Median 510(k) review, days · MTW

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

Recalls per year · MTW

No recall names MTW since 2007.

Adverse event reports per year · MTW

No MAUDE report names MTW 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 — MTW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MTW? 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

System, Water, Reproduction, Assisted, And Purification

What has FDA decided in MTW lately?