510(k) Report

510(k) · Cleared

Cleared

Storz Millennium Viscous Fluid System

K972664510(k) TraditionalCleared Oct 10, 199786-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Storz Instrument Co. · MRH Pump, Infusion, Ophthalmic

Cleared on Oct 10, 1997 as substantially equivalent to K961310 (Storz Instrument Co., 1996) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1990. 14 later devices descend from it.

Decided
Oct 10, 1997
Review
86 days
Class
Class II
Product code
MRH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K902835 (1990). 3 ancestors in all. 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 2 other ancestors2000: 1 descendant cleared2022: 2 descendants cleared2005: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK902835 · FTS-100 Fluid Transfer System · Richard James, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 4 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K902835 · FTS-100 Fluid Transfer System · Richard James, Inc. · 19900+5
  1. Root · 1 generation backK902835 FTS-100 Fluid Transfer SystemRichard James, Inc. · 1990
  2. This deviceK972664 Storz Millennium Viscous Fluid SystemStorz Instrument Co. · 1997
  3. Descendant · cites it directly · 13 of its ownK993039 Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000
  4. Descendant · 2 generations on · 11 of its ownK050716 Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005
  5. Descendant · 3 generations on · 10 of its ownK132494 Viscoelastic InjectorSight Sciences, Inc. · 2013
  6. Descendant · 4 generations on · 9 of its ownK143205 Viscoelastic InjectorSight Sciences, Inc. · 2014
  7. Descendant · 5 generations on · 8 of its ownK171905 VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2000: 12005: 12013: 12014: 12017: 22020: 12021: 22022: 22023: 12025: 12026: 1
2000high 2 (2017) · low 0 (2001)2026

Most influential descendants

Showing 5 of 14 · See all
  • K993039Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc. · 2000 · cites it directly13descendants
  • K050716Iscience Surgical ViscoinjectorIscience Surgical Corporation · 2005 · 2 generations on11descendants
  • K132494Viscoelastic InjectorSight Sciences, Inc. · 2013 · 3 generations on10descendants
  • K143205Viscoelastic InjectorSight Sciences, Inc. · 2014 · 4 generations on9descendants
  • K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc. · 2017 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902835FTS-100 Fluid Transfer SystemRichard James, Inc.1990—
0 (this device)K972664Storz Millennium Viscous Fluid SystemStorz Instrument Co.1997—
+1K993039Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc.2000—
+2K050716Iscience Surgical ViscoinjectorIscience Surgical Corporation2005—
+3K132494Viscoelastic InjectorSight Sciences, Inc.2013—
+4K143205Viscoelastic InjectorSight Sciences, Inc.2014—
+5K171905VISCO 360 Viscosurgical SystemSight Sciences, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200510
201310
201410
201720
202010
202120
202220
202310
202510
202610
FIG. 1 — Lineage of K972664, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253760 OMNI Ultra Surgical System (1-110)score 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K961310Storz Premiere II Microsurgical System (CX Series)
Summary page 1
…luid module. Predicate Device: The Storz CX5700 Millennium™ Viscous Fluid System Module is similar in design and function to the Storz Millennium™ Microsurgical System (K961310), Escalon® Viscous Fluid System (K963434), the Richard James Viscous Fluid Transfer System (K902835), and the Alcon Accurus™ Vitr…
Storz Instrument Co.19961
*K963434Viscous Fluid System
Summary page 1
…CX5700 Millennium™ Viscous Fluid System Module is similar in design and function to the Storz Millennium™ Microsurgical System (K961310), Escalon® Viscous Fluid System (K963434), the Richard James Viscous Fluid Transfer System (K902835), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX57…
Escalon Trek Medical1996—
*K902835FTS-100 Fluid Transfer System
Summary page 1
…in design and function to the Storz Millennium™ Microsurgical System (K961310), Escalon® Viscous Fluid System (K963434), the Richard James Viscous Fluid Transfer System (K902835), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5710 Viscous Fluid Injection Pack is similar in design, compo…
Richard James, Inc.1990—
*—Alcon Accurus™ Vitreoretinal Surgical System
Named without a submission number
—

Also cleared against K961310: 10 other devices →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993039Viscous Fluid Injector System Module (CX5700)Bausch & Lomb, Inc.200013

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K993039 (Bausch & Lomb, Inc., 2000) has gone furthest, with 13 descendants of its own.
  • 10 other devices also cite its predicate K961310.

How does its category compare?

All MRH devices

MRH Pump, Infusion, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRH

1in 2025

2013: 12014: 12017: 22020: 12021: 22022: 22023: 12025: 12026 (partial year): 1
2007high 2 (2017) · low 0 (2007)2026

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

2017: 282018: 12019: 22020: 62021: 22022: 162023: 312024: 202025: 14
2007high 31 (2023) · low 0 (2007)2025

MAUDE reports naming product code MRH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20141—00
20150—00
20160—00
20172—028
20180—01
20190—02
20201—06
20212—02
20222—016
20231—031
20240—020
20251—014
20261—0—

What is it indicated for?

The Storz Millennium™ Viscous Fluid System is a new device intended for the injection and aspiration of viscous fluids into and out of the eye during ophthalmic posterior vitreoretinal surgery. The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single use accessory pack.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K961310

10 other devices cite the same predicate.

  • K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 20101 recall
  • K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
  • K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 20094 recalls
  • K063583Alcon Vision SystemAlcon · 200811 recalls
  • K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 200612 recalls
  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20061 recall

More from Storz Instrument Co.

101 FDA decisions under this applicant name. See the company

  • K980100Storz DP4210 Venturi Economy Anterior Pack and DP5000 Asc DaypackStorz Instrument Co. · 1998
  • K980488Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 19984 recalls
  • K971439Storz Microflow and Storz Standard Phacoemulsification NeedlesStorz Instrument Co. · 1997
  • K964743Storz E8010 Ergotec/Premiere AdaptorStorz Instrument Co. · 1997
  • K960024Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchStorz Instrument Co. · 1996

Recent decisions in MRH

The MRH category page

  • K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc. · 2026
  • K243503VIA360™ Surgical SystemNew World Medical, Inc. · 2025
  • K232214OMNI Surgical SystemSight Sciences, Inc. · 2023
  • K213173TrabEx ProMicrosurgical Technologies, Inc. · 2022
  • K212797iPrime Viscodelivery SystemGlaukos · 2022

https://510kreport.com/device/K972664 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972664: Storz Millennium 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/K972664

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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