FDA product code HOM: Screen, Tangent, Ac-Powered (Campimeter)

HOM is the FDA product code for screen, tangent, ac-powered (campimeter). It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HOM. The average 510(k) review took 54 days (median 54).

Classification

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

Top HOM applicants

Most recent HOM clearances

Recalls for HOM devices

openFDA lists no recalls for product code HOM.

Frequently asked questions

What is FDA product code HOM?

HOM is the FDA product code for screen, tangent, ac-powered (campimeter). It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.

What device class is HOM?

Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).

Which companies have the most HOM clearances?

Biosan Laboratories, Inc. (1).

Next steps

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