# K221872: ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Nova Eye Inc. (Business Name Nova Eye Medical)
- Decided: Mar 30, 2023 after 275 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 4.

## Indications for use
The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery. The Nova Eye iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm's Canal to reduce intraocular pressure in adults patients with open-angle glaucoma.

Source page: https://510kreport.com/device/K221872
Methodology: https://510kreport.com/methodology