CapsoVision, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “CapsoVision, Inc.” (first 2016, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 138 days. Since 2017 the median was 138 days, against 124 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 |
|---|---|---|
| 2016 | 2 | 176 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 151 |
| 2020 | 1 | 142 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 92 |
| 2025 | 1 | 134 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CapsoVision, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 6 | 6 |
Review panels
Most recent CapsoVision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252480 | CE Deliver (DLV) | NEZ | 2025-12-19 | 134 |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | 2024-12-04 | 92 |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | NEZ | 2020-02-14 | 142 |
| K183192 | CapsoCam Plus (SV-3) | NEZ | 2019-04-19 | 151 |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | NEZ | 2016-10-21 | 115 |
| K151635 | CapsoCam (SV-1) | NEZ | 2016-02-09 | 237 |
Recalls
openFDA lists no recalls under a recalling firm named CapsoVision, Inc..
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.
SEC filings
CapsoVision, Inc (CV): EDGAR filings, CIK 1378325. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under CapsoVision, Inc.?
FDA lists 6 510(k) clearances under the applicant name “CapsoVision, Inc.” (first 2016, latest 2025), across 1 product code 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 CapsoVision, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CapsoVision, Inc. is 138 days. Since 2017: 138 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CapsoVision, Inc.?
The most frequent FDA product codes under this applicant name are NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule, 6).
Next steps
- See all 6 CapsoVision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEZ, CapsoVision, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.