FDA product code HOR: Simulatan (Including Crossed Cylinder)

HOR is the FDA product code for simulatan (including crossed cylinder). It is a Class I device, regulated under 21 CFR 886.1840 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HOR. The average 510(k) review took 33 days (median 33).

Classification

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

Top HOR applicants

Most recent HOR clearances

Recalls for HOR devices

openFDA lists no recalls for product code HOR.

Frequently asked questions

What is FDA product code HOR?

HOR is the FDA product code for simulatan (including crossed cylinder). It is a Class I device, regulated under 21 CFR 886.1840 and reviewed by the Ophthalmic panel.

What device class is HOR?

Class I, regulation 21 CFR 886.1840. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 33 days from receipt to decision (median 33).

Which companies have the most HOR clearances?

Richmond Products, Inc. (1).

Next steps

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