510(k) · Cleared
Recalled · Class II · 2018Iscience Interventional Ophthalmic Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iscience Interventional · MPA Endoilluminator
Cleared on Jul 18, 2008 as substantially equivalent to K041108 (Iscience Surgical Corporation, 2004) and 2 other predicates after a 190-day review. Its family tree reaches back 3 generations to 1988. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 18, 2008
- Review
- 190 days
- Class
- Class II
- Product code
- MPA
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K884043 (1988). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK884043 Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co. · 1988
- 2 generations backK973293 Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997
- 1 generation backK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
- This deviceK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008
- Descendant · cites it directly · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253468 Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · cites it directly6descendants
- K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 2 generations on2descendants
- K232214OMNI Surgical SystemSight Sciences, Inc. · 2023 · 3 generations on1descendant
- K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc. · 2026 · cites it directly0descendants
- K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 Gauge | Grieshaber & Co. | 1988 | — |
| −2 | K973293 | Syntec True Light End Irrigating Endoilluminator | Vaughan Weeks | 1997 | — |
| −1 | K041108 | Iscience Surgical Ophthalmic Microcannula | Iscience Surgical Corporation | 2004 | — |
| 0 (this device) | K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | 2008 | — |
| +1 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +2 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| +3 | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
| +1 | K253468 | Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A) | Nova Eye, Inc. | 2026 | — |
| +4 | K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K041108 | Iscience Surgical Ophthalmic MicrocannulaSummary page 1…nstrument Predicate Devices: Device Name 510(k) Number iScience Surgical Ophthalmic K041 108 Microcannula__ _ _ _ _ _ _ _ _… | 2004 |
| * | K970882 | Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.)Summary page 1…Microcannula__ _ _ _ _ _ _ _ _ Endolight End Irrigating K970882 Endoilluminator True Light End Irrigating K97… | 1997 |
| * | K973293 | Syntec True Light End Irrigating EndoilluminatorSummary page 1…Endolight End Irrigating K970882 Endoilluminator True Light End Irrigating K973293 Endoilluminator__ _ _ _ _ _ _ _ _ Description… | 1997 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2018 | Class II | Z-0011-2019 | Process control | Sterility failure found in one of the units in the lot. |
| Aug 6, 2014 | Class II | Z-2590-2014 | Under Investigation by firm | One lot may not have been properly sealed, resulting in a non-sterile device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173332 (Sight Sciences, Inc., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery.
The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adulit patients with open angle glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080067: Iscience Interventional Ophthalmic Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026