Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anx Robotica Corp — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
238 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpr | Anx Robotica Corp | 2024-07-31 | 29 | 0 |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | 2023-04-13 | 31 | 0 |
| K221608 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsul | Anx Robotica Corp | 2022-11-22 | 172 | 0 |
| K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021-05-04 | 188 | 0 |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | 2020-05-21 | 27 | 0 |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | 2019-12-18 | 238 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda