# K142263: Applanation Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Mediworks Precision Instruments Co., Ltd.
- Decided: Apr 15, 2016 after 610 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The T170 Applanation Tonometer is indicated for Intraocular Pressure (IOP) measurement .

Source page: https://510kreport.com/device/K142263
Methodology: https://510kreport.com/methodology
