510(k) Report

FDA applicant

Robling Medical

Youngsville, NC2 decisions2016–20160 recalls

FDA records 2 decisions for Robling Medical (Youngsville, NC) in 2016: 2 510(k) clearances. Most are in product codes GBM (Catheter, Urethral) and KOD (Catheter, Urological). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Robling Medical, Inc.”.

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 Robling Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2016: 2
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Robling 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?

  • GBMCatheter, Urethral1decision
  • KODCatheter, Urological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K160795United Urologics Intermittent CatheterRobling Medical · 2016
  • K160877United Urologics Closed System CatheterRobling Medical, Inc. · 2016

The one decision as Robling Medical →The one decision as Robling Medical, Inc. →