# K202678: OMNI Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Sight Sciences, Inc.
- Decided: Mar 1, 2021 after 167 days
- Product code: MRH (Pump, Infusion, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K902835 (1990). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173332: OMNI Surgical System, Sight Sciences, Inc. (2017) Summary page 4.

## Most influential descendants
- K232214: OMNI Surgical System (2023), 1 descendant of its own
- K253760: OMNI Ultra Surgical System (1-110) (2026), 0 descendants of its own

## Indications for use
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Source page: https://510kreport.com/device/K202678
Methodology: https://510kreport.com/methodology