Anx Robotica Corp: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Anx Robotica Corp” (first 2019, latest 2025), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 123 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 238 |
| 2020 | 1 | 27 |
| 2021 | 1 | 188 |
| 2022 | 1 | 172 |
| 2023 | 2 | 62 |
| 2024 | 2 | 64 |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Anx Robotica Corp took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QKZ | Magnetically Maneuvered Capsule Endoscopy System | 6 | 5 |
| FFX | System, Gastrointestinal Motility (Electrical) | 2 | 2 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 1 | 1 |
| NYV | Gastrointestinal Motility System, Capsule | 1 | 1 |
Review panels
Most recent Anx Robotica Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250493 | MotiliCap GI Monitoring System | NYV | 2025-05-21 | 90 |
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | QKZ | 2024-07-31 | 29 |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | NEZ | 2024-01-05 | 99 |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | QKZ | 2023-10-03 | 92 |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | QKZ | 2023-04-13 | 31 |
| 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 | QKZ | 2022-11-22 | 172 |
| K203192 | NaviCam Xpress Stomach System | QKZ | 2021-05-04 | 188 |
| K201106 | IntraMarX 3D Radiopaque Marker | FFX | 2020-05-21 | 27 |
| K191087 | IntraMarX Radiopaque Markers | FFX | 2019-12-18 | 238 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190037 | De Novo | Magnetically Maneuvered Capsule Endoscopy System | 2020-05-22 |
Recalls
openFDA lists no recalls under a recalling firm named Anx Robotica Corp.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Anx Robotica Corp is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04605302: Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms (Completed, started 2021-02-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Anx Robotica Corp?
FDA lists 9 510(k) clearances under the applicant name “Anx Robotica Corp” (first 2019, latest 2025), plus 1 De Novo decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Anx Robotica Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Anx Robotica Corp is 92 days. Since 2017: 92 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Anx Robotica Corp?
The most frequent FDA product codes under this applicant name are QKZ (Magnetically Maneuvered Capsule Endoscopy System, 6); FFX (System, Gastrointestinal Motility (Electrical), 2); NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule, 1).
Next steps
- See all 9 Anx Robotica Corp clearances with predicates and recalls
- Run predicate analysis for product code QKZ, Anx Robotica Corp's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.