510(k) · Cleared
ClearedIscience Surgical Viscoinjector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iscience Surgical Corporation · MRH Pump, Infusion, Ophthalmic
Cleared on Apr 21, 2005 as substantially equivalent to K993039 (Bausch & Lomb, Inc., 2000) and 3 other predicates after a 31-day review. Its family tree reaches back 3 generations to 1990. 11 later devices descend from it.
- Decided
- Apr 21, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K902835 (1990). 7 ancestors in all, the oldest K890783 (1989). 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 2 generations backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- 1 generation backK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- This deviceK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- Descendant · cites it directly · 10 of its ownK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- Descendant · 2 generations on · 9 of its ownK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
- Descendant · 3 generations on · 8 of its ownK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · 5 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132494Viscoelastic InjectorSight Sciences, Inc. · 2013 · cites it directly10descendants
- K143205Viscoelastic InjectorSight Sciences, Inc. · 2014 · 2 generations on9descendants
- K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017 · 3 generations on8descendants
- K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 4 generations on6descendants
- K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −2 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| −1 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| 0 (this device) | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| +1 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| +2 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
| +3 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| +4 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +5 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K993039 | Viscous Fluid Injector System Module (CX5700)Summary page 2…ing predicate devices: Company: Viscous Fluid Injector System Module (CX5700) Device: Bausch & Lomb Inc. 510(k): K993039 Company: Grieshaber & Co. Device: Grieshaber Viscoelastic Injection System 510(k):… | 2000 |
| * | K890783 | Grieshaber Viscoelastic Injection SystemSummary page 2…510(k): K993039 Company: Grieshaber & Co. Device: Grieshaber Viscoelastic Injection System 510(k): K890783 Company: D.O.R.C VFI VFE System Device: Dutch Ophthalmic USA, INC. 510(k):… | 1989 |
| * | K954842 | D.O.R.C. Vfi/Vfe SystemSummary page 2…m 510(k): K890783 Company: D.O.R.C VFI VFE System Device: Dutch Ophthalmic USA, INC. 510(k): K954842 Company: Viscous Fluid System Device: Escalon Trek Medical 510(k): K9634… | 1996 |
| * | K963434 | Viscous Fluid SystemSummary page 2…USA, INC. 510(k): K954842 Company: Viscous Fluid System Device: Escalon Trek Medical 510(k): K963434 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS The intended use and technological features of the iScience Surgical Ophthalmi… | 1996 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132494 | Viscoelastic Injector | 2013 | 10 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K132494 (Sight Sciences, Inc., 2013) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K993039.
How does its category compare?
All MRH devicesMRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 iScience Surgical Ophthalmic Viscolnjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050716 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050716: Iscience Surgical Viscoinjector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050716
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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