510(k) · Cleared
ClearedKarl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 12, 1994 after a 313-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- Sep 12, 1994
- Review
- 313 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 5 citing it directly.
- This deviceK935279 Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz…KARL STORZ Endoscopy-America, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK161838 Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK100577 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK221004 HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK193315 Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK110097 Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K161838Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016 · cites it directly6descendants
- K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · cites it directly4descendants
- K221004HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2022 · cites it directly3descendants
- K193315Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 2020 · 2 generations on3descendants
- K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935279 | Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid… | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| +1 | K161838 | Xenocor Xenoscope Laparoscopic System | Xenocor, Inc. | 2016 | — |
| +1 | K100577 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
| +1 | K221004 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2022 | — |
| +2 | K193315 | Xenocor Articulating Xenoscope Laparoscope | Xenocor, Inc. | 2020 | — |
| +2 | K110097 | Acclarent Cyclops Multi-Angle Endoscope | Acclarent, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (20)
See all 205 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, K161838 (Xenocor, Inc., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
https://510kreport.com/device/K935279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935279: Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935279
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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