510(k) · Cleared
ClearedOMNI Ultra Surgical System (1-110)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sight Sciences, Inc. · MRH Pump, Infusion, Ophthalmic
Cleared on Aug 4, 2026 as substantially equivalent to K232214 (Sight Sciences, Inc., 2023) after a 252-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Aug 4, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K902835 (1990). 20 ancestors in all, the oldest K884043 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 6 generations between
- 3 generations backK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- 2 generations backK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- 1 generation backK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- This deviceK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 9 generations backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- 8 generations backK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- 7 generations backK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- 6 generations backK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- 5 generations backK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
- 4 generations backK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- 3 generations backK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- 2 generations backK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- 1 generation backK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- This deviceK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −9 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| −8 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| −7 | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| −6 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| −5 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
| −4 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| −3 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| −2 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| −1 | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
| 0 (this device) | K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 MRH? 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 MRH device
- #1 K232214 OMNI Surgical Systemscore 11.3 · 9 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 |
|---|---|---|---|
| * | K232214 | OMNI Surgical SystemSummary page 5…trabeculotome Predicate Device Device Name: OMNI Surgical System 510(k) Holder: Sight Sciences, Inc. 510(k) Number: K232214 Clearance Date: August 25, 2023 Indications for Use The OMNI® Ultra Surgical System is indicated for cana… | 2023 |
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 36 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 20 ancestors have a recall of any class.
How does its category compare?
All MRH devicesMRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MRH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRH
Too few MRH 510(k)s in any year since 2007 to give a median.
Recalls per year · MRH
No recall names MRH since 2007.
Adverse event reports per year · MRH
14in 2025
MAUDE reports naming product code MRH, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 2 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 31 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OMNI Ultra 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.
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/K253760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253760: OMNI Ultra Surgical System (1-110).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253760
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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