FDA product code · General and plastic surgery

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

OJUClass I21 CFR 878.48001 decision since 19787 recalls

1 FDA decision since 1978. 7 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, general and plastic surgery panel

Twenty years of OJU 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 · OJU

FDA has decided no OJU device since 2007.

Median 510(k) review, days · OJU

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

Recalls per year · OJU

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OJU

2in 2025

2007high 88 (2021) · low 0 (2007)2025

MAUDE reports naming product code OJU, 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	2
2011	—	0	1
2012	—	2	6
2013	—	1	2
2014	—	0	0
2015	—	0	0
2016	—	0	2
2017	—	0	6
2018	—	0	2
2019	—	0	1
2020	—	0	9
2021	—	0	88
2022	—	0	41
2023	—	0	4
2024	—	0	4
2025	—	1	2
2026	—	3	—

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

Planning a device in OJU? 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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Other codes under 21 CFR 878.4800.

PYH Surgical Retractor Kit PXS Cholecystectomy Kit PYF Sterile Puncture Tray GDN Knife, Amputation PIR Mercy Tape 2d And 3d Models DWO Needle, Biopsy, Cardiovascular HBT Applier, Hemostatic Clip GAD Retractor MCZ Suture Removal Kit GAE Snare, Surgical HCF Instrument, Ligature Passing And Knot Tying GDZ Handle, Scalpel

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What has FDA decided in OJU lately?

What has been recalled in OJU lately?

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