# K253468: Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

- Pathway: 510(k) (Traditional)
- Applicant: Nova Eye, Inc.
- Decided: Aug 10, 2026 after 305 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884043 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080067: Iscience Interventional Ophthalmic Microcatheter, Iscience Interventional (2008) Summary page 5.

## Indications for use
The Nova Eye iTrack™ 250A is indicated for fluid infusion and aspiration during surgery. The Nova Eye iTrack™ 250A is indicated for catheterization and viscodilation of Schlemm’s canal to reduce intraocular pressure in adult patients with open angle glaucoma.

Source page: https://510kreport.com/device/K253468
Methodology: https://510kreport.com/methodology