FDA product code NAI: Lens, Prescription, Color Deficiency

NAI is the FDA product code for lens, prescription, color deficiency. It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NAI. The average 510(k) review took 358 days (median 358). FDA has posted 1 recall for NAI devices, 1 initiated in the last five years.

Classification

Compare with all 510(k) review times · Search every NAI clearance

Top NAI applicants

Most recent NAI clearances

Recalls for NAI devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-09-06.

Frequently asked questions

What is FDA product code NAI?

NAI is the FDA product code for lens, prescription, color deficiency. It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel.

What device class is NAI?

Class I, regulation 21 CFR 886.5844. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code NAI?

Across 1 cleared submissions the average was 358 days from receipt to decision (median 358).

Which companies have the most NAI clearances?

Color Vision Technologies, Inc. (1).

Have NAI devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-09-06.

Next steps

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