510(k) · Cleared
ClearedViscous Fluid System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Escalon Trek Medical · MRH Pump, Infusion, Ophthalmic
Cleared on Nov 25, 1996 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- Nov 25, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK963434 Viscous Fluid SystemEscalon Trek Medical · 1996
- Descendant · cites it directly · 14 of its ownK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- Descendant · 2 generations on · 13 of its ownK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
- Descendant · cites it directly · 11 of its ownK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
- Descendant · 2 generations on · 10 of its ownK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
- Descendant · 3 generations on · 9 of its ownK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K972664Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997 · cites it directly14descendants
- K993039Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000 · 2 generations on13descendants
- K050716Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005 · cites it directly11descendants
- K132494Viscoelastic InjectorSight Sciences, Inc. · 2013 · 2 generations on10descendants
- K143205Viscoelastic InjectorSight Sciences, Inc. · 2014 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963434 | Viscous Fluid System | Escalon Trek Medical | 1996 | — |
| +1 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| +2 | K993039 | Viscous Fluid Injector System Module (CX5700) | Bausch & Lomb, Inc. | 2000 | — |
| +1 | K050716 | Iscience Surgical Viscoinjector | Iscience Surgical Corporation | 2005 | — |
| +2 | K132494 | Viscoelastic Injector | Sight Sciences, Inc. | 2013 | — |
| +3 | K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 163 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?
- Of its descendants, K972664 (Storz Instrument Co., 1997) has gone furthest, with 14 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.
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 | — |
https://510kreport.com/device/K963434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963434: Viscous Fluid System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963434
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026