510(k) · Cleared
ClearedNaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam 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 Nov 22, 2022 as substantially equivalent to DEN190037 (Anx Robotica, Inc., 2020) and 1 other predicate after a 172-day review. Its family tree reaches back 2 generations to 2020. 2 later devices descend from it.
- Decided
- Nov 22, 2022
- Review
- 172 days
- Class
- Class II
- Product code
- QKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN190037 (2020). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN190037 NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleAnx Robotica, Inc. · 2020
- 1 generation backK203192 NaviCam Xpress Stomach SystemAnx Robotica Corp · 2021
- This deviceK221608 NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and…Anx Robotica Corp · 2022
- Descendant · cites it directly · 1 of its ownK231960 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK241934 NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress…Anx Robotica Corp · 2024
Most influential descendants
Showing 2 of 2 · See all- K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Anx Robotica Corporation · 2023 · cites it directly1descendant
- K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with…Anx Robotica Corp · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020 | — |
| −1 | K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 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? (2)
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…terology/Urology 4. PREDICATE DEVICES Primary – NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam System”) granted the De-Novo submission under DEN190037. NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) cleared under K203192. Reference – Given Imaging… | 2020 |
| * | K203192 | NaviCam Xpress Stomach SystemSummary page 4…Capsule (“NaviCam System”) granted the De-Novo submission under DEN190037. NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) cleared under K203192. Reference – Given Imaging PillCam® Express™ Video Capsule Delivery Device (“PillCam Delivery Device”) cleared under K101200. 5.… | 2021 |
| † | K101200 | Pillcam Express Video Capsules Delivery Device | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with… | 2023 | 1 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231960 (Anx Robotica Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate DEN190037.
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. 2022, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221608 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221608: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221608
Report an extraction error
Are you the manufacturer?
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