510(k) Report

FDA applicant

Ureteral Stent Company

Chagrin Falls, OH2 decisions2022–20240 recalls

FDA records 2 decisions for Ureteral Stent Company (Chagrin Falls, OH) from 2022 to 2024: 2 510(k) clearances. All are in product code FAD (Stent, Ureteral). Its devices cite 3 predicates, 1 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 Ureteral Stent Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Ureteral Stent Company by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FADStent, Ureteral2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company · 20222cite it

What has FDA decided for it lately?

  • K232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x…Ureteral Stent Company · 2024
  • K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company · 2022

All 2 as Ureteral Stent Company →