DeviceClearance

Product code HKX— Ophthalmic

ACCUPEN

Classification name
Tonometer, Ac-Powered
Device class
Class 2
Regulation
21 CFR 886.1930
Advisory panel
Ophthalmic
Total cleared
58
First cleared
Most recent

Market context for product code HKX

FDA has cleared 58 devices under product code HKX between 1980 and 2025, filed by 45 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HKX

Recent clearances under product code HKX

Data sourced from openFDA. This site is unofficial and independent of the FDA.