Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

QKZ · Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

172 daysmedian FDA review time
283 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam XprAnx Robotica Corp2024-07-31290
K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam XprAnx Robotica Corporation2023-10-03920
K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp2023-04-13310
K221608NaviCam Capsule Endoscope System with NaviCam Stomach CapsulAnx Robotica Corp2022-11-221720
K203192NaviCam Xpress Stomach SystemAnx Robotica Corp2021-05-041880
DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsulAnx Robotica, Inc.2020-05-222830

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