# K152308: Sensor Medical Single Use Tonometer Prism

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medical Technology, LLC
- Decided: Oct 13, 2015 after 60 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: 1 generation back to K023838 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023838: Luneau Sterile Tonometer Separation Prisms, Luneau SA (2003) Summary page 4.

## Indications for use
The Sensor Medical Single Use Tonometer Prism is intended for use as a disposable applanating and optical doubling prism for Goldmann style applanation tonometers.

Source page: https://510kreport.com/device/K152308
Methodology: https://510kreport.com/methodology