510(k) · Cleared
ClearedNaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anx Robotica Corporation · QKZ Magnetically Maneuvered Capsule Endoscopy System
Cleared on Oct 3, 2023 as substantially equivalent to K221608 (Anx Robotica Corp, 2022) after a 92-day review. Its family tree reaches back 3 generations to 2020. 1 later device descends from it.
- Decided
- Oct 3, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN190037 (2020). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN190037 NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. · 2020
- 2 generations backK203192 NaviCam Xpress Stomach SystemAnx Robotica Corp · 2021
- 1 generation backK221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and…Anx Robotica Corp · 2022
- This deviceK231960 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corporation · 2023
- Descendant · cites it directly · 0 of its ownK241934 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corp · 2024
Most influential descendants
Showing 1 of 1 · See all- K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Anx Robotica Corp · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020 | — |
| −2 | 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 | — |
| 0 (this device) | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corporation | 2023 | — |
| +1 | K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corp | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K241934 NaviCam Xpress Stomach Capsule Endoscope…score 8.7 · 4 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 |
|---|---|---|---|
| * | K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether…Summary page 4…PREDICATE DEVICES Primary – NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (K221608). References – Given PillCam Platform with PillCam SB Capsules with PillCam SensorBelt (K103088) and Given PillCam Plat… | 2022 |
| † | K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt | 2011 |
| † | K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with… | 2024 | 0 |
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 3 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241934 (Anx Robotica Corp, 2024) has gone furthest, with 0 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. 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 Xpress Stomach Capsule is intended for visualization of the stomach of patients => 6 years old with BMI =< 65 and a waist circumference =< 77 inches. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231960 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231960
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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