510(k) · Cleared
ClearedNaviCam Xpress Stomach System, NaviCam Xpress 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 Apr 13, 2023 as substantially equivalent to K203192 (Anx Robotica Corp, 2021) after a 31-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Apr 13, 2023
- Review
- 31 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190037 (2020). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K203192 | NaviCam Xpress Stomach SystemSummary page 4…tion Panel: Gastroenterology/Urology 4. PREDICATE DEVICES Primary predicate– NaviCam Xpress Stomach system (NaviCam Xpress system) cleared under the 510(k) submission K203192. Reference– NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (hereafter “NaviCam Stomach System”) granted the De-No… | 2021 |
| † | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K203192.
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. 2023, 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) with BMI < 38. The system can be used in clinics and hospitals, including ER settings.
The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach for a stomach capsule endoscopy (MCCE) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230694: NaviCam Xpress Stomach System, NaviCam Xpress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230694
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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