FDA product code · Anesthesiology

Spinal Anesthesia Kit

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

OFUClass II21 CFR 868.51200 decisions3 recalls

0 FDA decisions. 3 recalls name this code, 3 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, anesthesiology panel

Twenty years of OFU 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 · OFU

FDA has decided no OFU device since 2007.

Median 510(k) review, days · OFU

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

Recalls per year · OFU

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · OFU

19in 2025

2007high 28 (2024) · low 0 (2007)2025

MAUDE reports naming product code OFU, 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	2
2015	—	0	0
2016	—	0	2
2017	—	0	6
2018	—	0	13
2019	—	0	11
2020	—	0	6
2021	—	0	13
2022	—	0	13
2023	—	0	19
2024	—	0	28
2025	—	0	19
2026	—	3 (3)	—

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

Planning a device in OFU? 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 868.5120.

MAJ Catheter, Percutaneous, Intraspinal, Short Term OFV Regional Anesthesia Kit OGF Glossopharyngeal Anesthesia Kit OFT Spinal Epidural Anesthesia Kit BSO Catheter, Conduction, Anesthetic OGE Epidural Anesthesia Kit OGD Custom Anesthesia Tray OFQ Anesthesia Kit

Spinal Anesthesia Kit

What has been recalled in OFU lately?

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