# Neptune Medical, Inc.

- Location (FDA's records): Burlingame, CA
- FDA decisions: 7 (2019–2026): 7 510(k) clearances
- Product codes: FED (5), FDS (1), FDF (1)
- 510(k) review time since 2016: median 91 days, against 98 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)
- Kms Medical, LLC: 1 (https://510kreport.com/company/kms-medical)
- Motus GI Medical Technologies, Ltd.: 1 (https://510kreport.com/company/motus-gi-medical-technologies)
- Neoguide Systems, Inc.: 1 (https://510kreport.com/company/neoguide-systems)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Firms that cite its devices most
- FUJIFILM Healthcare Americas Corporation: 1 (https://510kreport.com/company/fujifilm-healthcare-americas)

## Its most-cited devices
- K211301: Pathfinder Endoscope Overtube (2021), cited by 3
- K191415: Pathfinder Endoscope Overtube (2019), cited by 3

## Recent decisions
- K262262: Pathfinder Endoscope Overtube (Sep 18, 2026)
- K260503: Triton 1 System (Sep 3, 2026)
- K240853: Pathfinder® CR System (Jun 27, 2024)
- K230801: Pathfinder Endoscope Overtube with Balloon Device (Jul 28, 2023)
- K211301: Pathfinder Endoscope Overtube (May 28, 2021)
- K210915: Pathfinder Endoscope Cap (May 25, 2021)
- K191415: Pathfinder Endoscope Overtube (Aug 30, 2019)

Source page: https://510kreport.com/company/neptune-medical