510(k) · Cleared
ClearedQEVO System with KINEVO 900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · GWG Endoscope, Neurological
Cleared on Aug 18, 2017 after a 165-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Aug 18, 2017
- Review
- 165 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK170667 QEVO System with KINEVO 900Carl Zeiss Meditec, AG · 2017
- Descendant · cites it directly · 1 of its ownK222735 HJY VisualNext Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK243429 HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232159 QEVO SystemCarl Zeiss Meditec, AG · 2023
Most influential descendants
Showing 3 of 3 · See all- K222735HJY VisualNext Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2023 · cites it directly1descendant
- K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2025 · 2 generations on0descendants
- K232159QEVO SystemCarl Zeiss Meditec, AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170667 | QEVO System with KINEVO 900 | Carl Zeiss Meditec, AG | 2017 | — |
| +1 | K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2023 | — |
| +2 | K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | 2025 | — |
| +1 | K232159 | QEVO System | Carl Zeiss Meditec, AG | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
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, K222735 (Hjy Smart Medical Device Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
https://510kreport.com/device/K170667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170667: QEVO System with KINEVO 900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170667
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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