510(k) Report

FDA applicant

Neptune Medical, Inc.

Burlingame, CA7 decisions2019–20260 recalls

FDA records 7 decisions for Neptune Medical, Inc. (Burlingame, CA) from 2019 to 2026: 7 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and FDS (Gastroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Neptune Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12021: 22023: 12024: 12026 (partial year): 2
2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Neptune Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neptune Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology5decisions
  • FDSGastroscope And Accessories, Flexible/Rigid1decision
  • FDFColonoscope And Accessories, Flexible/Rigid1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211301Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 20213cite it
  • K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 20193cite it

What has FDA decided for it lately?

  • K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
  • K260503Triton 1 SystemNeptune Medical, Inc. · 2026
  • K240853Pathfinder® CR SystemNeptune Medical, Inc. · 2024
  • K230801Pathfinder Endoscope Overtube with Balloon DeviceNeptune Medical, Inc. · 2023
  • K211301Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2021
  • K210915Pathfinder Endoscope CapNeptune Medical, Inc. · 2021
  • K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2019

All 7 as Neptune Medical, Inc. →