FDA product code · Obstetrics and gynecology

Obstetrical Kit

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

OKVClass II21 CFR 884.45200 decisions40 recalls

0 FDA decisions. 40 recalls name this code, 14 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 OKV 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 · OKV

FDA has decided no OKV device since 2007.

Median 510(k) review, days · OKV

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

Recalls per year · OKV

1in 2025

2007high 14 (2014) · low 0 (2007)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · OKV

7in 2025

2007high 7 (2025) · low 0 (2007)2025

MAUDE reports naming product code OKV, 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	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	14 (14)	0
2015	—	0	0
2016	—	0	0
2017	—	0	3
2018	—	0	0
2019	—	0	0
2020	—	0	3
2021	—	0	1
2022	—	0	2
2023	—	0	1
2024	—	13	4
2025	—	1	7
2026	—	12	—

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

Planning a device in OKV? 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 884.4520.

HDG Speculum, Vaginal, Metal, Fiberoptic KOH Instrument, Manual, General…HGD Applicator, Vaginal HGC Clamp, Uterine HDM Packer, Uterine HDK Scissors, Episiotomy HDJ Scissors, Umbilical HDE Hook, Fibroid, Gynecological HDF Speculum, Vaginal, Metal HER Pelvimeter, External HDL Retractor, Vaginal OKU Emergency Obstetrical Kit

Obstetrical Kit

What has been recalled in OKV lately?

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