FDA product code · Cardiovascular

Catheter Guide Wire Kit

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

OFBClass II21 CFR 870.13300 decisions2 recalls

0 FDA decisions. 2 recalls name this code, 1 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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…

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 OFB 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 · OFB

FDA has decided no OFB device since 2007.

Median 510(k) review, days · OFB

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

Recalls per year · OFB

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OFB

4in 2021

2007high 4 (2021) · low 0 (2007)2025

MAUDE reports naming product code OFB, 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	1
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	2
2020	—	0	0
2021	—	0	4
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	2 (1)	—

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

Planning a device in OFB? 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 870.1330.

PTL Wire, Guide, Catheter, Exempt MOF Guide, Wire, Catheter, Neurovasculature DQX Wire, Guide, Catheter NKQ Guidewire, Catheter, Reprocessed

Catheter Guide Wire Kit

What has been recalled in OFB lately?

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