FDA product code · Obstetrics and gynecology

Device, Engorgement, Clitoral

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

NBVClass II21 CFR 884.5970510(k) required3 decisions since 20000 recalls

3 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 NBV 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 · NBV

FDA has decided no NBV device since 2007.

Median 510(k) review, days · NBV

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

Recalls per year · NBV

No recall names NBV since 2007.

Adverse event reports per year · NBV

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

Planning a device in NBV? 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

Device, Engorgement, Clitoral

What has FDA decided in NBV lately?