510(k) · Cleared
ClearedViscous Fluid Injector System Module (CX5700)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · MRH Pump, Infusion, Ophthalmic
Cleared on Jan 7, 2000 as substantially equivalent to K972664 (Storz Instrument Co., 1997) after a 119-day review. Its family tree reaches back 2 generations to 1990. 13 later devices descend from it.
- Decided
- Jan 7, 2000
- Review
- 119 days
- Class
- Class II
- Product code
- MRH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902835 (1990). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
- 1 generation backK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
- This deviceK993039 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
- Descendant · 4 generations on · 8 of its ownK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017
- Descendant · 5 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- 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
- K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017 · 4 generations on8descendants
- K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902835 | FTS-100 Fluid Transfer System | Richard James, Inc. | 1990 | — |
| −1 | K972664 | Storz Millennium Viscous Fluid System | Storz Instrument Co. | 1997 | — |
| 0 (this device) | 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 | — |
| +4 | K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017 | — |
| +5 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K972664 | Storz Millennium Viscous Fluid SystemSummary page 1…5700) is a self-contained pump system used in conjunction with the Storz Millennium™ Microsurgical System (K961310). The Storz Millennium™ Viscous Fiuid Injector System (K972664) is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous flu… | 1997 |
| † | K961310 | Storz Premiere II Microsurgical System (CX Series) | 1996 |
| † | K963434 | Viscous Fluid System | 1996 |
| † | K902835 | FTS-100 Fluid Transfer System | 1990 |
What descends from it? (13)
See all 132 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 10 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050716 (Iscience Surgical Corporation, 2005) has gone furthest, with 11 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 | — |
What is it indicated for?
The Storz Millennium™ Viscous Fluid System is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgery. The Storz viscous fluid system consiste of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single-use accessory pack consisting of an infusion lube set, a syringe, a Cannula and instructions for use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993039: Viscous Fluid Injector System Module (CX5700).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993039
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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