510(k) · Cleared
ClearedOMNI PLUS 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 11, 2020 as substantially equivalent to K173332 (Sight Sciences, Inc., 2017) after a 28-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Aug 11, 2020
- Review
- 28 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). No later device cites it as a predicate yet.
- 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 deviceK201953 OMNI PLUS Surgical SystemSight Sciences, Inc. · 2020
View 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) | K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020 | — |
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 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…RH Secondary Product Code: HMZ Predicate Device Device Name: OMNI® Surgical System 510(k) Holder: Sight Sciences, Inc. 510(k) Number: K173332 Clearance Date: December 21, 2017 Intended Use The OMNI® PLUS Surgical System is an ophthalmic surgical tool for the de… | 2017 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 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. 2020, 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® PLUS Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® PRO or Healon GV® PRO from Johnson & Johnson Vision, Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201953 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201953: OMNI PLUS Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201953
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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