FDA product code · Obstetrics and gynecology

Breast Pump Kit

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

OHHClass II21 CFR 884.51600 decisions1 recall

0 FDA decisions. 1 recall names this code; it is not Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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 OHH 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 · OHH

FDA has decided no OHH device since 2007.

Median 510(k) review, days · OHH

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

Recalls per year · OHH

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHH

1in 2025

2007high 2 (2019) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in OHH? 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

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