FDA product code OGG: Humidifier Nebulizer Kit

OGG is the FDA product code for humidifier nebulizer kit. It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel. Devices under OGG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for OGG 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 OGG devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-13.

Frequently asked questions

What is FDA product code OGG?

OGG is the FDA product code for humidifier nebulizer kit. It is a Class II device, regulated under 21 CFR 868.5450 and reviewed by the Anesthesiology panel.

What device class is OGG?

Class II, regulation 21 CFR 868.5450. Typical premarket route: 510(k) exempt.

Have OGG devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2026-07-13.

Next steps

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