510(k) Report

FDA product code · Obstetrics and gynecology

Tampon, Menstrual, Scented, Scented-Deodorized

HILClass II21 CFR 884.5460510(k) required84 decisions since 19760 recalls

84 FDA decisions since 1976. No recall names this code. The most-cited predicate is K070745, named by 4 later devices.

A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

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 HIL 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 · HIL

1in 2014

2007: 22008: 22012: 22013: 12014: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIL

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

Recalls per year · HIL

No recall names HIL since 2007.

Adverse event reports per year · HIL

1in 2025

2007: 82008: 82009: 132010: 112011: 42012: 22013: 92014: 32015: 32016: 42017: 22018: 12019: 12020: 122021: 72022: 22023: 12024: 12025: 1
2007high 13 (2009) · low 1 (2018)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—08
20082—08
20090—013
20100—011
20110—04
20122—02
20131—09
20141—03
20150—03
20160—04
20170—02
20180—01
20190—01
20200—012
20210—07
20220—02
20230—01
20240—01
20250—01
20260—0—
FIG. 1 — HIL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HIL? 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