De Novo · Granted
GrantedNaviCam Capsule Endoscope System with NaviCam Stomach Capsule
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anx Robotica, Inc. · QKZ Magnetically Maneuvered Capsule Endoscopy System
Granted on May 22, 2020 as a new device type through De Novo after a 283-day review. 5 later devices descend from it.
- Decided
- May 22, 2020
- Review
- 283 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN190037 NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK203192 NaviCam Xpress Stomach SystemAnx Robotica Corp · 2021
- Descendant · cites it directly · 2 of its ownK221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and…Anx Robotica Corp · 2022
- Descendant · 2 generations on · 1 of its ownK231960 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK241934 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corp · 2024
- Descendant · 2 generations on · 0 of its ownK230694 NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp · 2023
Most influential descendants
Showing 5 of 5 · See all- K203192NaviCam Xpress Stomach SystemAnx Robotica Corp · 2021 · cites it directly4descendants
- K221608NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether…Anx Robotica Corp · 2022 · cites it directly2descendants
- K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Anx Robotica Corporation · 2023 · 2 generations on1descendant
- K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Anx Robotica Corp · 2024 · 3 generations on0descendants
- K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020 | — |
| +1 | K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021 | — |
| +1 | K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam… | Anx Robotica Corp | 2022 | — |
| +2 | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corporation | 2023 | — |
| +3 | K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corp | 2024 | — |
| +2 | K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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 QKZ? 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 QKZ device
- #1 K231960 NaviCam Xpress Stomach Capsule Endoscope…score 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
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, K203192 (Anx Robotica Corp, 2021) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QKZ devicesQKZ Magnetically Maneuvered Capsule Endoscopy System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QKZ
Too few QKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QKZ
No recall names QKZ since 2007.
Adverse event reports per year · QKZ
No MAUDE report names QKZ since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (≥22 years old) with a BMI less than 38. The system can be used in clinics and hospitals, including ER settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190037 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN190037: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN190037
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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