510(k) Report

FDA applicant

Brightwater Medical

Dunlap, IL2 decisions2016–20190 recalls

FDA records 2 decisions for Brightwater Medical (Dunlap, IL) from 2016 to 2019: 2 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and FAD (Stent, Ureteral). Its devices cite 3 predicates, 0 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 Brightwater Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Brightwater Medical by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts1decision
  • FADStent, Ureteral1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K181669ConvertX Biliary Stent SystemBrightwater Medical · 2019
  • K161277ConvertX Nephroureteral Stent SystemBrightwater Medical · 2016

All 2 as Brightwater Medical →