FDA product code · Anesthesiology

Spinal Epidural Anesthesia Kit

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

OFTClass II21 CFR 868.51200 decisions20 recalls

0 FDA decisions. 20 recalls name this code, 2 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 OFT 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 · OFT

FDA has decided no OFT device since 2007.

Median 510(k) review, days · OFT

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

Recalls per year · OFT

13so far in 2026, the most since 2007

2007high 13 (2026) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · OFT

56in 2025

2007high 71 (2024) · low 0 (2007)2025

MAUDE reports naming product code OFT, 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	1
2009	—	0	2
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	1
2014	—	0	12
2015	—	0	6
2016	—	1	3
2017	—	0	7
2018	—	0	7
2019	—	0	20
2020	—	0	14
2021	—	0	6
2022	—	1	22
2023	—	0	23
2024	—	4	71
2025	—	1	56
2026	—	13 (2)	—

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

Planning a device in OFT? 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 OFU Spinal Anesthesia Kit OGF Glossopharyngeal Anesthesia Kit BSO Catheter, Conduction, Anesthetic OGE Epidural Anesthesia Kit OGD Custom Anesthesia Tray OFQ Anesthesia Kit

Spinal Epidural Anesthesia Kit

What has been recalled in OFT lately?

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