Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CapsoVision, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
237 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 2025-12-19 | 134 | 0 |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024-12-04 | 92 | 0 |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2020-02-14 | 142 | 0 |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | 2019-04-19 | 151 | 0 |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | CapsoVision, Inc. | 2016-10-21 | 115 | 0 |
| K151635 | CapsoCam (SV-1) | CapsoVision, Inc. | 2016-02-09 | 237 | 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