FDA product code · Obstetrics and gynecology

Pad, Menstrual, Unscented

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

HHDClass I21 CFR 884.5435510(k) exempt136 decisions since 19760 recalls

FDA lists HHD 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. 136 FDA decisions since 1976. No recall names this code. The most-cited predicate is K844601, named by 1 later device.

An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and 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 HHD 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 · HHD

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHD

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

Recalls per year · HHD

No recall names HHD since 2007.

Adverse event reports per year · HHD

11in 2025

2007high 16 (2023) · low 2 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	0	—	4
2009	0	—	3
2010	0	—	5
2011	0	—	3
2012	0	—	5
2013	0	—	3
2014	0	—	4
2015	0	—	6
2016	0	—	4
2017	0	—	4
2018	0	—	5
2019	0	—	6
2020	0	—	2
2021	0	—	5
2022	0	—	8
2023	0	—	16
2024	0	—	15
2025	0	—	11
2026	0	—	—

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

Planning a device in HHD? 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.

NUQ Pad, Menstrual, Reusable PVT Maternity Kit NUR Pad, Menstrual, Intralabial

Pad, Menstrual, Unscented

Which predicates do HHD devices cite most?

Which HHD devices have the deepest lineage?

What has FDA decided in HHD lately?

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