DeviceClearance

Product code HKY— Ophthalmic

ACCUTIP COVER

Classification name
Tonometer, Manual
Device class
Class 2
Regulation
21 CFR 886.1930
Advisory panel
Ophthalmic
Total cleared
56
First cleared
Most recent

Market context for product code HKY

FDA has cleared 56 devices under product code HKY between 1977 and 2024, filed by 42 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 HKY

Recent clearances under product code HKY

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