FDA product code · Neurology

Neurological Tray

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

OJGClass I21 CFR 882.45250 decisions53 recalls

0 FDA decisions. 53 recalls name this code, 6 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, neurology panel

Twenty years of OJG 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 · OJG

FDA has decided no OJG device since 2007.

Median 510(k) review, days · OJG

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

Recalls per year · OJG

19so far in 2026, the most since 2007

2007high 19 (2026) · low 0 (2007)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · OJG

6in 2025

2007high 39 (2024) · low 0 (2007)2025

MAUDE reports naming product code OJG, 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	—	5 (5)	1
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	7
2019	—	0	3
2020	—	0	8
2021	—	1	9
2022	—	17	11
2023	—	2	9
2024	—	6	39
2025	—	3	6
2026	—	19 (1)	—

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

Planning a device in OJG? 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

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What has been recalled in OJG lately?

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