510(k) · Cleared
ClearedNaviCam Xpress Stomach System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anx Robotica Corp · QKZ Magnetically Maneuvered Capsule Endoscopy System
Cleared on May 4, 2021 as substantially equivalent to DEN190037 (Anx Robotica, Inc., 2020) after a 188-day review. Its family tree reaches back 1 generation to 2020. 4 later devices descend from it.
- Decided
- May 4, 2021
- Review
- 188 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190037 (2020). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN190037 NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. · 2020
- This deviceK203192 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 · cites it directly · 0 of its ownK230694 NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp · 2023
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020 | — |
| 0 (this device) | 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 | — |
| +1 | K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleSummary page 4…ogy/Urology 4. PREDICATE DEVICES NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (NaviCam Stomach System) initially granted the De-Novo submission under DEN190037. 5. DEVICE DESCRIPTION The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of t… | 2020 |
What descends from it? (4)
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?
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. 2021, 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 Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <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/K203192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203192: NaviCam Xpress Stomach System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203192
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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