FDA product code · Cardiovascular

Ct Biopsy Tray

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

OFGClass II21 CFR 870.40750 decisions14 recalls

0 FDA decisions. 14 recalls name this code, 0 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 OFG 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 · OFG

FDA has decided no OFG device since 2007.

Median 510(k) review, days · OFG

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

Recalls per year · OFG

8so far in 2026, the most since 2007

2007high 8 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OFG

3in 2024

2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code OFG, 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	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	1
2020	—	0	0
2021	—	0	1
2022	—	1	0
2023	—	0	1
2024	—	4	3
2025	—	1	0
2026	—	8	—

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

Planning a device in OFG? 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 870.4075.

DWZ Device, Biopsy, Endomyocardial MFY Endothelial Cell Harvesting Kit

Ct Biopsy Tray

What has been recalled in OFG lately?

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