# K253176: TearView

- Pathway: 510(k) (Traditional)
- Applicant: Beyond 700 Pty, Ltd.
- Decided: Jun 22, 2026 after 269 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913929 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111771: Non-Contact Tear Film Thermogragh, United Integrated Services Co., Ltd. (2011) Summary page 5.

## Indications for use
TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas. TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) pattern of the ocular surface including its tear film during blinking.

Source page: https://510kreport.com/device/K253176
Methodology: https://510kreport.com/methodology