510(k) Report

FDA product code · Obstetrics and gynecology

Pad, Menstrual, Intralabial

NURClass I21 CFR 884.5435510(k) exempt0 decisions0 recalls

FDA lists NUR as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 884.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.

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 NUR 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.

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

Planning a device in NUR? 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

Related product codes

Other codes under 21 CFR 884.5435.