FDA product code · Cardiovascular

Angiography/Angioplasty Kit

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

OEQClass II21 CFR 870.16500 decisions39 recalls

0 FDA decisions. 39 recalls name this code, 7 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, cardiovascular panel

Twenty years of OEQ 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 · OEQ

FDA has decided no OEQ device since 2007.

Median 510(k) review, days · OEQ

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

Recalls per year · OEQ

13so far in 2026, the most since 2007

2007high 13 (2026) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · OEQ

108in 2025

2007high 108 (2025) · low 0 (2007)2025

MAUDE reports naming product code OEQ, 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	1
2012	—	0	0
2013	—	0	1
2014	—	6 (6)	0
2015	—	0	1
2016	—	0	3
2017	—	0	3
2018	—	1	14
2019	—	0	22
2020	—	11	64
2021	—	0	54
2022	—	5	81
2023	—	0	56
2024	—	2	62
2025	—	1	108
2026	—	13 (1)	—

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

Planning a device in OEQ? 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 870.1650.

OER Angioscopic Valvulotome Kit NKU Injector And Syringe, Angiographic, Balloon…MAV Syringe, Balloon Inflation DXT Injector And Syringe, Angiographic OFH Digital Angiography Tray IZQ Injector, Contrast Medium, Automatic PTM Syringe, Balloon Inflation, Exempt NKP Injector, Contrast Medium, Automatic…NKT Injector And Syringe, Angiographic, Reprocessed

Angiography/Angioplasty Kit

What has been recalled in OEQ lately?

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