FDA product code · Cardiovascular

Cardiovascular Procedure Kit

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

OEZClass II21 CFR 870.12000 decisions111 recalls

0 FDA decisions. 111 recalls name this code, 11 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 OEZ 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 · OEZ

FDA has decided no OEZ device since 2007.

Median 510(k) review, days · OEZ

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

Recalls per year · OEZ

37so far in 2026, the most since 2007

2007high 37 (2026) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · OEZ

122in 2025

2007high 199 (2010) · low 0 (2007)2025

MAUDE reports naming product code OEZ, 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	—	4	0
2009	—	5	0
2010	—	0	199
2011	—	2	185
2012	—	0	28
2013	—	0	7
2014	—	0	10
2015	—	0	28
2016	—	0	44
2017	—	0	42
2018	—	1	58
2019	—	0	71
2020	—	1	65
2021	—	1	42
2022	—	23	36
2023	—	5	24
2024	—	27 (1)	147
2025	—	5 (1)	122
2026	—	37 (9)	—

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

Planning a device in OEZ? 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 870.1200.

OWQ Reprocessed Intravascular Ultrasound Catheter ORD Optical Coherence Tomography, Intravascular…OBI Catheter, Pressure Monitoring, Cardiac OGZ Catheter, Intravascular, Plaque Morphology…OFN Winged Intravenous Catheterization Kit NUI Ultrasound, Infusion, System DQO Catheter, Intravascular, Diagnostic OES Cardiac Catheterization Kit OBJ Catheter, Ultrasound, Intravascular NLI Catheter, Angiography, Reprocessed

Cardiovascular Procedure Kit

What has been recalled in OEZ lately?

Related product codes