510(k) · Cleared
ClearedOMNI Surgical System
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 Mar 1, 2021 as substantially equivalent to K173332 (Sight Sciences, Inc., 2017) after a 167-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 1, 2021
- Review
- 167 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K902835 (1990). 18 ancestors in all, the oldest K884043 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 7 generations backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- 6 generations backK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- 5 generations backK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- 4 generations backK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- 3 generations backK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
- 2 generations backK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- 1 generation backK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- This deviceK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −7 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| −6 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| −5 | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| −4 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| −3 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
| −2 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| −1 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| 0 (this device) | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| +1 | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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 K253760 OMNI Ultra Surgical System (1-110)score 14.5 · 10 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 |
|---|---|---|---|
| * | K173332 | OMNI Surgical SystemSummary page 4…oduct Code: HMZ Primary Predicate Device Device Name: OMNI® Surgical System 510(k) Holder: Sight Sciences, Inc. 510(k) Number: K173332 Clearance Date: December 21, 2017 Reference Device Device Name: iScience Interventional Canaloplasty M… | 2017 |
| † | K080067 | Iscience Interventional Ophthalmic Microcatheter | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232214 | OMNI Surgical System | 2023 | 1 |
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 31 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K232214 (Sight Sciences, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K173332.
How does its category compare?
All MRH devicesMRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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® 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/K202678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202678: OMNI Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202678
Report an extraction error
Are you the manufacturer?
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