510(k) · Cleared
Recalled · 2010Storz Premiere II Microsurgical System (CX Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HQC Unit, Phacofragmentation
Cleared on Jun 27, 1996 after an 84-day review. The FDA summary names its predicate without a number. 78 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 0
78 later devices descend from it, 11 citing it directly.
- This deviceK961310 Storz Premiere II Microsurgical System (CX Series)Storz Instrument Co. · 1996
- Descendant · cites it directly · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- Descendant · cites it directly · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · cites it directly · 32 of its ownK060366 The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · Recalled
- Descendant · cites it directly · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K021566InfinitiAlcon Laboratories, Inc. · 2002 · cites it directly50descendants
- K063583Alcon Vision SystemAlcon · 2008 · cites it directly36descendants
- K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006 · cites it directly32descendants
- K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · cites it directly24descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 2 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961310 | Storz Premiere II Microsurgical System (CX Series) | Storz Instrument Co. | 1996 | — |
| +1 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| +1 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +1 | K060366 | The Amo Ophthalmic Surgical System | Advanced Medical Optics, Inc. | 2006 | 1 |
| +1 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| +2 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
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 |
|---|---|---|---|
| * | — | Storz PREMIERE® Microsurgical System Named without a submission number | |
| * | — | Alcon Series 20000® Legacy™ Microsurgical System Named without a submission number | |
| * | — | SITE TXR™ System Named without a submission number | |
| * | — | Chiron CATALYST™ Microsurgical System Named without a submission number | |
| * | — | Storz DP8020 Phaco and DP7020 Frag Handpieces Named without a submission number | |
| * | — | Grieshaber MPC and PSS Microscissors Named without a submission number | |
| * | — | Storz ErgoTec™ Vitreoretinal Instrument System Named without a submission number | |
| * | — | Storz DP4800 Posterior Vitrectomy Pack Named without a submission number | |
| * | — | Storz DP4310 Deluxe Phaco Pack Named without a submission number | |
| * | — | Storz DP9404 Bipolar Adaptor Named without a submission number | |
| * | — | Storz D8204 Reusable Bipolar Cable Named without a submission number | |
| * | — | Storz S2070 C Disposable Bipolar Cable Named without a submission number |
What descends from it? (78)
See all 7811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021566 | Infiniti | 2002 | 50 |
| K063583 | Alcon Vision System | 2008 | 36 |
| K060366 | The Amo Ophthalmic Surgical System | 2006 | 32 |
| K063331 | Bausch & Lomb NGX Microsurgical System | 2006 | 24 |
| K082473 | Bausch & Lomb Stellaris Microsurgical System | 2009 | 22 |
| K101325 | Stellaris PC Vision Enhancement System | 2010 | 14 |
| K972664 | Storz Millennium Viscous Fluid System | 1997 | 14 |
| K081877 | Associate 2500 Dual and Compact Systems | 2009 | 8 |
| K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | 1998 | 1 |
| K983797 | D.O.R.C. Harmony Total Vitrectomy System | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2010 | Not classified | Z-1663-2010 | Nonconforming Material/Component | The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021566 (Alcon Laboratories, Inc., 2002) has gone furthest, with 50 descendants of its own.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The Storz PREMIERE II is a modular ophthalmic microsurgical system which is designed to be configured by Storz for use in anterior segment surgery only, posterior segment surgery only, or both.
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/K961310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961310: Storz Premiere II Microsurgical System (CX Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961310
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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