510(k) · Cleared
ClearedKarl Storz 3D Video System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Imaging, Inc. · GCI Laryngoscope, Endoscope
Cleared on Jul 17, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jul 17, 2000
- Review
- 80 days
- Class
- Class II
- Product code
- GCI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK001362 Karl Storz 3D Video SystemKarl Storz Imaging, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK083728 Invision SystemInneroptic Technology, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK121479 AIMInneroptic Technology, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK141806 Clear Guide OneClear Guide Medical · 2014
- Descendant · 3 generations on · 1 of its ownK132744 Acessa Guidance SystemHalt Medical, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK101979 Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083728Invision SystemInneroptic Technology, Inc. · 2009 · cites it directly8descendants
- K121479AIMInneroptic Technology, Inc. · 2012 · 2 generations on5descendants
- K141806Clear Guide OneClear Guide Medical · 2014 · 3 generations on2descendants
- K132744Acessa Guidance SystemHalt Medical, Inc. · 2014 · 3 generations on1descendant
- K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001362 | Karl Storz 3D Video System | Karl Storz Imaging, Inc. | 2000 | — |
| +1 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| +2 | K121479 | AIM | Inneroptic Technology, Inc. | 2012 | — |
| +3 | K141806 | Clear Guide One | Clear Guide Medical | 2014 | — |
| +3 | K132744 | Acessa Guidance System | Halt Medical, Inc. | 2014 | — |
| +2 | K101979 | Explorer Liver (Passive Tracking) | Pathfinder Therapeutics, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 GCI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083728 | Invision System | 2009 | 8 |
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, K083728 (Inneroptic Technology, Inc., 2009) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GCI devicesGCI Laryngoscope, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCI
FDA has decided no GCI device since 2007.
Median 510(k) review, days · GCI
Too few GCI 510(k)s in any year since 2007 to give a median.
Recalls per year · GCI
No recall names GCI since 2007.
Adverse event reports per year · GCI
121in 2025
MAUDE reports naming product code GCI, 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 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 49 |
| 2012 | 0 | — | 0 | 55 |
| 2013 | 0 | — | 0 | 50 |
| 2014 | 0 | — | 0 | 106 |
| 2015 | 0 | — | 0 | 177 |
| 2016 | 0 | — | 0 | 100 |
| 2017 | 0 | — | 0 | 130 |
| 2018 | 0 | — | 0 | 102 |
| 2019 | 0 | — | 0 | 135 |
| 2020 | 0 | — | 0 | 129 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 102 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 119 |
| 2025 | 0 | — | 0 | 121 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001362: Karl Storz 3D Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001362
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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