FDA product code · Obstetrics and gynecology

Pad, Menstrual, Scented, Scented-Deodorized

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

HHLClass II21 CFR 884.5425510(k) exempt57 decisions since 19760 recalls

FDA lists HHL 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. 57 FDA decisions since 1976. No recall names this code.

Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).

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 HHL 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 · HHL

FDA has decided no HHL device since 2007.

Median 510(k) review, days · HHL

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

Recalls per year · HHL

No recall names HHL since 2007.

Adverse event reports per year · HHL

8in 2025

2007high 8 (2025) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	0
2009	—	1
2010	—	0
2011	—	2
2012	—	1
2013	—	3
2014	—	1
2015	—	0
2016	—	4
2017	—	1
2018	—	0
2019	—	3
2020	—	0
2021	—	0
2022	—	1
2023	—	5
2024	—	1
2025	—	8
2026	—	—

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

Planning a device in HHL? 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 884.5425.

NRC Pad, Menstrual, Scented, Scented-Deodorized…

Pad, Menstrual, Scented, Scented-Deodorized

What has FDA decided in HHL lately?

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