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 Aug 25, 2023 as substantially equivalent to K202678 (Sight Sciences, Inc., 2021) after a 30-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Aug 25, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K902835 (1990). 19 ancestors in all, the oldest K884043 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 5 generations between
- 3 generations backK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- 2 generations backK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- 1 generation backK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- This deviceK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 8 generations backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- 7 generations backK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- 6 generations backK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- 5 generations backK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- 4 generations backK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
- 3 generations backK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- 2 generations backK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- 1 generation backK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- This deviceK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −8 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| −7 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| −6 | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| −5 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| −4 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
| −3 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| −2 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| −1 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| 0 (this device) | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K202678 | OMNI Surgical SystemSummary page 4…ry Product Code: HMZ Predicate Device Device Name: OMNI® Surgical System 510(k) Holder: Sight Sciences, Inc. 510(k) Number: K202678 Clearance Date: March 1, 2021 Reference Device Device Name OMNI® PLUS Surgical System 510(k) Holder… | 2021 |
| † | K201953 | OMNI PLUS Surgical System | 2020 |
| † | K080067 | Iscience Interventional Ophthalmic Microcatheter | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110) | 2026 | 0 |
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 33 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K253760 (Sight Sciences, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MRH devicesMRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232214: 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/K232214
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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