510(k) · Cleared
ClearedStorz MVS 1011A Disposable Fiberoptic Endoilluminator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 26, 1996 as substantially equivalent to K854587 (Storz Instrument Co., 1986) after an 84-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Mar 26, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854587 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854587 Storz MVS Disposable Fiberoptic LightpipeStorz Instrument Co. · 1986
- This deviceK960007 Storz MVS 1011A Disposable Fiberoptic EndoilluminatorStorz · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854587 | Storz MVS Disposable Fiberoptic Lightpipe | Storz Instrument Co. | 1986 | — |
| 0 (this device) | K960007 | Storz MVS 1011A Disposable Fiberoptic Endoilluminator | Storz | 1996 | — |
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 MPA? 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 MPA device
- #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 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 |
|---|---|---|---|
| * | K854587 | Storz MVS Disposable Fiberoptic LightpipeSummary page 1…inator. Predicate Device: The Storz MVS 1011A Fiberoptic Endoilluminator is substantially equivalent to its predecessor, the Storz MVS 1011 Fiberoptic Endoilluminator (K854587). Predicate Comparison: A chart comparing the Storz MVS 1011A with the Storz MVS 1011, showing substantial equivalence, is attac… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K854587.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, 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 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MVS 1011A is intended to be used as an accessory to the Storz PREMIERE® and Storz DAISY™ Microsurgical Systems, as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures.
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/K960007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960007: Storz MVS 1011A Disposable Fiberoptic Endoilluminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960007
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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