Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neptune Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
127 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | 2024-06-27 | 91 | 0 |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. | 2023-07-28 | 127 | 0 |
| K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2021-05-28 | 29 | 0 |
| K210915 | Pathfinder Endoscope Cap | Neptune Medical, Inc. | 2021-05-25 | 57 | 0 |
| K191415 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | 2019-08-30 | 94 | 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