510(k) · Cleared
ClearedNaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
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 Jul 31, 2024 as substantially equivalent to K231960 (Anx Robotica Corporation, 2023) after a 29-day review. Its family tree reaches back 4 generations to 2020.
- Decided
- Jul 31, 2024
- Review
- 29 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN190037 (2020). No later device cites it as a predicate yet.
- Root · 4 generations backDEN190037 NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. · 2020
- 3 generations backK203192 NaviCam Xpress Stomach SystemAnx Robotica Corp · 2021
- 2 generations backK221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and…Anx Robotica Corp · 2022
- 1 generation backK231960 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corporation · 2023
- This deviceK241934 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corp · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020 | — |
| −3 | K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021 | — |
| −2 | K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam… | Anx Robotica Corp | 2022 | — |
| −1 | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corporation | 2023 | — |
| 0 (this device) | K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach… | Anx Robotica Corp | 2024 | — |
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 |
|---|---|---|---|
| * | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Summary page 5…ology 4. PREDICATE DEVICES Primary – NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (K231960). Reference – NaviCam Small Bowel Capsule Endoscope System with NaviCam SB Capsule/Tether (K233229). 5. DEVICE DE… | 2023 |
| † | K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | 2024 |
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 4 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
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. 2024, 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 patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 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 as stated in the FDA summary.
https://510kreport.com/device/K241934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241934: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241934
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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