FDA product code · General hospital

Intravenous Extension Tubing Set

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

OJAClass II21 CFR 880.54401 decision since 19871 recall

1 FDA decision since 1987. 1 recall names this code; it is not 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 hospital panel

Twenty years of OJA 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 · OJA

FDA has decided no OJA device since 2007.

Median 510(k) review, days · OJA

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

Recalls per year · OJA

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OJA

1in 2025

2007high 9 (2020) · low 0 (2007)2025

MAUDE reports naming product code OJA, 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	3
2010	—	0	1
2011	—	0	0
2012	—	0	1
2013	—	0	2
2014	—	0	0
2015	—	0	0
2016	—	0	1
2017	—	0	0
2018	—	0	0
2019	—	0	5
2020	—	0	9
2021	—	0	6
2022	—	0	3
2023	—	0	1
2024	—	0	4
2025	—	0	1
2026	—	1	—

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

Planning a device in OJA? 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 880.5440.

POQ Blood Transfusion Kit FMG Stopcock, I.V. Set PWQ Buret Administration Intravenous Kit FPK Tubing, Fluid Delivery FPA Set, Administration, Intravascular CAK Microfilter, Blood Transfusion NEP System/Device, Pharmacy Compounding PWH Administrations Sets With Neuraxial Connectors MJF Check Valve, Retrograde Flow (In-Line)PYR Neuraxial Administration Set - Intrathecal…LHI Set, I.V. Fluid Transfer ODI Administration Set Docking Station

Intravenous Extension Tubing Set

What has FDA decided in OJA lately?

What has been recalled in OJA lately?

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