510(k) · Cleared
ClearedStorz MVS-3201 Vitrectomy Probe Pack
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 Sep 14, 1995 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 14, 1995
- Review
- 45 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK953575 Storz MVS-3201 Vitrectomy Probe PackStorz Instrument Co. · 1995
- Descendant · cites it directly · 2 of its ownK954816 Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic…Storz Instrument Co. · 1996
- Descendant · 2 generations on · 1 of its ownK980488 Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · Recalled
- Descendant · 3 generations on · 0 of its ownK031404 Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003
- Descendant · cites it directly · 0 of its ownK990292 I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior…Ophthalmic Consultants, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK960003 Storz D7116 Microvit Vitrectomy Cutter ExtensionStorz Instrument Co. · 1996
Most influential descendants
Showing 5 of 5 · See all- K954816Storz DP4800 Deluxe , Storz DP4801 Basic W/Reflux, DP4801 Basic Posterior Vitrectomy…Storz Instrument Co. · 1996 · cites it directly2descendants
- K980488Storz Millennium Microsurgicl System High Speed Vitrectomy SystemStorz Instrument Co. · 1998 · 2 generations on1descendant
- K031404Dignity Ophthalmic Surgical SystemPhacor Inc., A Santen Company · 2003 · 3 generations on0descendants
- K990292I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack…Ophthalmic Consultants, Inc. · 1999 · cites it directly0descendants
- K960003Storz D7116 Microvit Vitrectomy Cutter ExtensionStorz Instrument Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K980488 | Storz Millennium Microsurgicl System High Speed Vitrectomy System | Storz Instrument Co. | 1998 | 4 |
| +3 | K031404 | Dignity Ophthalmic Surgical System | Phacor Inc., A Santen Company | 2003 | — |
| +1 | K990292 | I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy… | Ophthalmic Consultants, Inc. | 1999 | — |
| +1 | K960003 | Storz D7116 Microvit Vitrectomy Cutter Extension | Storz Instrument Co. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K954816 (Storz Instrument Co., 1996) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K953575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953575: Storz MVS-3201 Vitrectomy Probe Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953575
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026