FDA product code · Obstetrics and gynecology

Cesarean Section Tray

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

OHMClass II21 CFR 884.17200 decisions29 recalls

0 FDA decisions. 29 recalls name this code, 9 of them 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 OHM 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 · OHM

FDA has decided no OHM device since 2007.

Median 510(k) review, days · OHM

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

Recalls per year · OHM

10so far in 2026, the most since 2007

2007high 10 (2026) · low 0 (2007)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · OHM

19in 2025

2007high 32 (2024) · low 0 (2007)2025

MAUDE reports naming product code OHM, 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	—	5	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	2
2013	—	0	0
2014	—	8 (8)	0
2015	—	0	0
2016	—	0	1
2017	—	0	8
2018	—	0	2
2019	—	0	10
2020	—	0	8
2021	—	0	3
2022	—	1	3
2023	—	2	7
2024	—	1	32
2025	—	2	19
2026	—	10 (1)	—

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

Planning a device in OHM? 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 884.1720.

OCQ Laparoscopic Bladder-Neck Suspension…OKX Trocar Kit OHD Gynecological Laparoscopic Kit NMH Laparoscope And Accessories, Gynecologic…HET Laparoscope, Gynecologic (And Accessories)NWV Laparoscopic Accessories, Gynecologic

Cesarean Section Tray

What has been recalled in OHM lately?

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