510(k) · Cleared
ClearedStorz MVS Disposable Fiberoptic Lightpipe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz Instrument Co. · HBI Illuminator, Fiberoptic, Surgical Field
Cleared on Feb 4, 1986 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 4, 1986
- Review
- 78 days
- Class
- Class II
- Product code
- HBI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK854587 Storz MVS Disposable Fiberoptic LightpipeStorz Instrument Co. · 1986
- Descendant · cites it directly · 2 of its ownK961036 Mbi Fiberoptic Endo-IlluminatorM.B. Industries, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK964553 Mbi CO-Axial Illuminated Retinal PickM.B. Industries, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK964405 Mbi Illuminated Retinal PickM.B. Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK960007 Storz MVS 1011A Disposable Fiberoptic EndoilluminatorStorz · 1996
Most influential descendants
Showing 4 of 4 · See all- K961036Mbi Fiberoptic Endo-IlluminatorM.B. Industries, Inc. · 1996 · cites it directly2descendants
- K964553Mbi CO-Axial Illuminated Retinal PickM.B. Industries, Inc. · 1997 · 2 generations on0descendants
- K964405Mbi Illuminated Retinal PickM.B. Industries, Inc. · 1997 · 2 generations on0descendants
- K960007Storz MVS 1011A Disposable Fiberoptic EndoilluminatorStorz · 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) | K854587 | Storz MVS Disposable Fiberoptic Lightpipe | Storz Instrument Co. | 1986 | — |
| +1 | K961036 | Mbi Fiberoptic Endo-Illuminator | M.B. Industries, Inc. | 1996 | — |
| +2 | K964553 | Mbi CO-Axial Illuminated Retinal Pick | M.B. Industries, Inc. | 1997 | — |
| +2 | K964405 | Mbi Illuminated Retinal Pick | M.B. Industries, Inc. | 1997 | — |
| +1 | K960007 | Storz MVS 1011A Disposable Fiberoptic Endoilluminator | Storz | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 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 HBI? 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 HBI device
- #1 K223183 Light-Guide Cablesscore 5.0 · 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? (4)
2 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, K961036 (M.B. Industries, Inc., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HBI devicesHBI Illuminator, Fiberoptic, Surgical Field: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HBI
Too few HBI 510(k)s in any year since 2007 to give a median.
Recalls per year · HBI
No recall names HBI since 2007.
Adverse event reports per year · HBI
1in 2025
MAUDE reports naming product code HBI, 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 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854587: Storz MVS Disposable Fiberoptic Lightpipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854587
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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