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 Dec 21, 2017 as substantially equivalent to K080067 (Iscience Interventional, 2008) and 1 other predicate after a 59-day review. Its family tree reaches back 7 generations to 1990. 6 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 59 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902835 (1990). 17 ancestors in all, the oldest K884043 (1988). 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 6 generations backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- 5 generations backK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- 4 generations backK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- 3 generations backK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- 2 generations backK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
- 1 generation backK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- This deviceK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253760 OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243503 VIA360™ Surgical SystemNew World Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK211680 Streamline Surgical SystemNew World Medical, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · cites it directly2descendants
- K232214OMNI Surgical SystemSight Sciences, Inc. · 2023 · 2 generations on1descendant
- K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026 · 3 generations on0descendants
- K243503VIA360™ Surgical SystemNew World Medical, Inc. · 2025 · cites it directly0descendants
- K211680Streamline Surgical SystemNew World Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −6 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| −5 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| −4 | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| −3 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| −2 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
| −1 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| 0 (this device) | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +1 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| +2 | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
| +3 | K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026 | — |
| +1 | K243503 | VIA360™ Surgical System | New World Medical, Inc. | 2025 | — |
| +1 | K211680 | Streamline Surgical System | New World Medical, Inc. | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K080067 | Iscience Interventional Ophthalmic MicrocatheterSummary page 4…halmic) PREDICATE DEVICES: DEVICE NAME 510(K) NUMBER iTrack Catheter (Ellex) K080067 * primary predicate device VISCO360 Viscosurgical System… | 2008 |
| * | K171905 | VISCO 360 Viscosurgical SystemSummary page 4…eter (Ellex) K080067 * primary predicate device VISCO360 Viscosurgical System K171905 (Sight Sciences) REFERENCE DEVICES: DEVICE NAME 510(K)… | 2017 |
What descends from it? (6)
4 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)
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 27 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K202678 (Sight Sciences, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K080067.
How does its category compare?
All MRH devicesMRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics (AMO), 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/K173332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173332: 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/K173332
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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