510(k) · Cleared
Recalled · 2007Storz Millennium Microsurgicl System High Speed Vitrectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Mar 23, 1998 as substantially equivalent to K961310 (Storz Instrument Co., 1996) and 3 other predicates after a 42-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Mar 23, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- HQE
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 2 generations to K953575 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953575 Storz MVS-3201 Vitrectomy Probe PackStorz Instrument Co. · 1995
- 1 generation backK954816 Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic…Storz Instrument Co. · 1996
- This deviceK980488 Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998
- Descendant · cites it directly · 0 of its ownK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
Most influential descendants
Showing 1 of 1 · See all- K031404Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953575 | Storz MVS-3201 Vitrectomy Probe Pack | Storz Instrument Co. | 1995 | — |
| −1 | K954816 | Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior… | Storz Instrument Co. | 1996 | — |
| 0 (this device) | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | Storz Instrument Co. | 1998 | — |
| +1 | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K961310 | Storz Premiere II Microsurgical System (CX Series)Summary page 1…vices: The Storz CX5800 Millennium™ System High Speed Vitrectomy module is substantially equivalent in design and function to the Storz Millennium™ Microsurgical System (K961310), Promex Vitrectomy System (K961078), Scieran Technologies VIT Commander System (K961738), and the Alcon Accurus™ Vitreoretinal S… | 1996 |
| * | K961078 | Automated Vitrectomy DeviceSummary page 1…System High Speed Vitrectomy module is substantially equivalent in design and function to the Storz Millennium™ Microsurgical System (K961310), Promex Vitrectomy System (K961078), Scieran Technologies VIT Commander System (K961738), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5810 Mil… | 1996 |
| * | K961738 | Vit Commander SystemSummary page 1…equivalent in design and function to the Storz Millennium™ Microsurgical System (K961310), Promex Vitrectomy System (K961078), Scieran Technologies VIT Commander System (K961738), and the Alcon Accurus™ Vitreoretinal Surgical System. The Storz CX5810 Millennium™ High Speed Vitrectomy handpiece is substanti… | 1996 |
| * | K954816 | Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior Vitrectomy…Summary page 1…Accurus™ Vitreoretinal Surgical System. The Storz CX5810 Millennium™ High Speed Vitrectomy handpiece is substantially equivalent to the Storz MicroVit Vitrectomy Probe (K954816 and K961310), Promex Vitrectomy handpiece (K961078), Alcon Accurus InnoVit Probe, and the Scieran Vit Commander System handpiece… | 1996 |
| * | — | Alcon Accurus Vitreoretinal Surgical System Named without a submission number | |
| * | — | Alcon Accurus InnoVit Probe Named without a submission number | |
| * | — | Alcon Accurus Total Plus Pak Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031404 | Dignity Ophthalmic Surgical System | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2007 | Not classified | Z-0766-2007 | Other | The cutter probe tip breaks during use. |
| Feb 9, 2007 | Not classified | Z-0765-2007 | Other | The cutter probe tip breaks during use. |
| Dec 14, 2006 | Not classified | Z-0496-2007 | Other | The cutter tip could break during a procedure |
| Dec 14, 2006 | Not classified | Z-0495-2007 | Other | The cutter tip could break during a procedure |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K031404 (Phacor Inc., A Santen Company, 2003) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K961310.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 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.
https://510kreport.com/device/K980488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980488: Storz Millennium Microsurgicl System High Speed Vitrectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980488
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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