FDA product code · Cardiovascular

Cardiac Catheterization Kit

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

OESClass II21 CFR 870.12000 decisions68 recalls

0 FDA decisions. 68 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 OES 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 · OES

FDA has decided no OES device since 2007.

Median 510(k) review, days · OES

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

Recalls per year · OES

27so far in 2026, the most since 2007

2007high 27 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OES

115in 2025

2007high 115 (2025) · low 0 (2007)2025

MAUDE reports naming product code OES, 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	1
2013	—	0	3
2014	—	0	3
2015	—	0	3
2016	—	0	4
2017	—	0	3
2018	—	1	12
2019	—	15	13
2020	—	0	35
2021	—	0	21
2022	—	2	13
2023	—	2	18
2024	—	19	113
2025	—	2	115
2026	—	27 (11)	—

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

Planning a device in OES? 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 OEZ Cardiovascular Procedure Kit OGZ Catheter, Intravascular, Plaque Morphology…OFN Winged Intravenous Catheterization Kit NUI Ultrasound, Infusion, System DQO Catheter, Intravascular, Diagnostic OBJ Catheter, Ultrasound, Intravascular NLI Catheter, Angiography, Reprocessed

Cardiac Catheterization Kit

What has been recalled in OES lately?

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