510(k) · Cleared
ClearedKarl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Nov 16, 1995 after a 716-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
- Nov 16, 1995
- Review
- 716 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK935716 Karl Storz Fixed Magnification Telescope/KS Variable Magnification…KARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK223520 UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK254252 UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating…Karl Storz SE & CO. KG · 2026
- Descendant · 2 generations on · 0 of its ownK261102 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
- Descendant · cites it directly · 0 of its ownK223885 HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK141515 Aed Hysteroscope and AccessoriesNational Advanced Endoscopy Devices, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc. · 2023 · cites it directly2descendants
- K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD)…Karl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K223885HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2023 · cites it directly0descendants
- K141515Aed Hysteroscope and AccessoriesNational Advanced Endoscopy Devices, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935716 | Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023 | — |
| +2 | K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath… | Karl Storz SE & CO. KG | 2026 | — |
| +2 | K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
| +1 | K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023 | — |
| +1 | K141515 | Aed Hysteroscope and Accessories | National Advanced Endoscopy Devices, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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, K223520 (Karl Storz-Endoscopy-America, Inc., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
https://510kreport.com/device/K935716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935716: Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935716
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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