510(k) · Cleared
ClearedNova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Eye, Inc. · MPA Endoilluminator
Cleared on Aug 10, 2026 as substantially equivalent to K080067 (Iscience Interventional, 2008) after a 305-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Aug 10, 2026
- Review
- 305 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K884043 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK884043 Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co. · 1988
- 3 generations backK973293 Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997
- 2 generations backK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
- 1 generation backK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
- This deviceK253468 Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 Gauge | Grieshaber & Co. | 1988 | — |
| −3 | K973293 | Syntec True Light End Irrigating Endoilluminator | Vaughan Weeks | 1997 | — |
| −2 | K041108 | Iscience Surgical Ophthalmic Microcannula | Iscience Surgical Corporation | 2004 | — |
| −1 | K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | 2008 | 2 |
| 0 (this device) | K253468 | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | Nova Eye, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MPA device
- #1 K233653 Midfield Light Pipe, 23ga (3269.M06-00)…score 9.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080067 | Iscience Interventional Ophthalmic MicrocatheterSummary page 5…21 CFR 886.4350 (HMX) Device Classification: Class 2 III. Predicate Device Predicate Device • iTrack™ 250A Canaloplasty Microcatheter (Nova Eye, Inc.) (K080067) IV. Device Description The Nova Eye iTrack™ 250A Canaloplasty Microcatheter (“iTrack™ 250A”) is a flexible microcathete… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K080067.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253468: Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253468
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026