FDA product code OGI: Nasal Endotracheal Tube Holder Kit

OGI is the FDA product code for nasal endotracheal tube holder kit. It is a Class I device, regulated under 21 CFR 868.5770 and reviewed by the Anesthesiology panel. Devices under OGI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OGI devices, 1 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Classification

Recalls for OGI devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-27.

Frequently asked questions

What is FDA product code OGI?

OGI is the FDA product code for nasal endotracheal tube holder kit. It is a Class I device, regulated under 21 CFR 868.5770 and reviewed by the Anesthesiology panel.

What device class is OGI?

Class I, regulation 21 CFR 868.5770. Typical premarket route: 510(k) exempt.

Have OGI devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2026-04-27.

Next steps

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