# K232143: Applanation Tonometer HT-5000

- Pathway: 510(k) (Traditional)
- Applicant: Huvitz Co., Ltd.
- Decided: Oct 23, 2023 after 96 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981432 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133234: T-Type D-Kat, R-Type D-Kat, Keeler Limited (2014) Summary page 5.

## Indications for use
The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.

Source page: https://510kreport.com/device/K232143
Methodology: https://510kreport.com/methodology