Neptune Medical, Inc.: FDA clearances and approvals
Neptune Medical, Inc. has 7 FDA 510(k) clearances (first 2019, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 91 days. Since 2017 its median was 91 days, against 133 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 94 |
| 2020 | 0 | — |
| 2021 | 2 | 43 |
| 2022 | 0 | — |
| 2023 | 1 | 127 |
| 2024 | 1 | 91 |
| 2025 | 0 | — |
| 2026 | 2 | 138 |
Review time against the same product codes
Since 2017, Neptune Medical, Inc.'s cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 5 | 5 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Neptune Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262262 | Pathfinder Endoscope Overtube | FED | 2026-09-18 | 78 |
| K260503 | Triton 1 System | FDF | 2026-09-03 | 198 |
| K240853 | Pathfinder® CR System | FED | 2024-06-27 | 91 |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | FED | 2023-07-28 | 127 |
| K211301 | Pathfinder Endoscope Overtube | FED | 2021-05-28 | 29 |
| K210915 | Pathfinder Endoscope Cap | FDS | 2021-05-25 | 57 |
| K191415 | Pathfinder Endoscope Overtube | FED | 2019-08-30 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Neptune Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Neptune Medical, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06571760: Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I (Completed, started 2024-09-10)
Frequently asked questions
How many FDA 510(k) clearances does Neptune Medical, Inc. have?
Neptune Medical, Inc. has 7 FDA 510(k) clearances (first 2019, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Neptune Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Neptune Medical, Inc.'s cleared 510(k)s is 91 days. Since 2017: 91 days, versus 133 days for all cleared 510(k)s in the same product codes.
What devices does Neptune Medical, Inc. make?
Its most frequent FDA product codes are FED (Endoscopic Access Overtube, Gastroenterology-Urology, 5); FDF (Colonoscope And Accessories, Flexible/Rigid, 1); FDS (Gastroscope And Accessories, Flexible/Rigid, 1).
Has Neptune Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Neptune Medical, Inc. Related entities may recall under other names.
Next steps
- See all 7 Neptune Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FED, Neptune Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.