FDA product code OFT: Spinal Epidural Anesthesia Kit

OFT is the FDA product code for spinal epidural anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel. Devices under OFT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 40 recalls for OFT devices, 30 initiated in the last five years.

Definition

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.

Classification

Recalls for OFT devices

40 product recalls in 28 recall events; 30 initiated in the last five years and 30 still open. Most recent: 2026-07-31.

Frequently asked questions

What is FDA product code OFT?

OFT is the FDA product code for spinal epidural anesthesia kit. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel.

What device class is OFT?

Class II, regulation 21 CFR 868.5120. Typical premarket route: 510(k) exempt.

Have OFT devices been recalled?

Yes: 40 product recalls across 28 recall events; the most recent began 2026-07-31.

Next steps

• Run an FDA pathway report with predicate devices for product code OFT
• Run a recall and safety report across every OFT manufacturer
• Watch product code OFT for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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