510(k) Report

FDA applicant

Vitalcare, Inc.

Miami, FL3 decisions2003–20030 recalls

FDA records 3 decisions for Vitalcare, Inc. (Miami, FL) in 2003: 3 510(k) clearances. Most are in product codes GBM (Catheter, Urethral) and EZD (Catheter, Straight). 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 Vitalcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vitalcare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vitalcare, Inc. by year, 2007–2026Sources: 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
  • EZDCatheter, Straight1decision
  • EZLCatheter, Retention Type, Balloon1decision

What has FDA decided for it lately?

  • K021938Vitalcare Urethral CatheterVitalcare, Inc. · 2003
  • K021939Vitalcare Foley CatheterVitalcare, Inc. · 2003
  • K023872Vitalcare Urethral Catheter Red RubberVitalcare, Inc. · 2003

All 3 as Vitalcare, Inc. →

Other applicant names beginning “Vitalcare”

FDA records each applicant name separately; these may or may not be the same firm.

Vitalcare Group, Inc. 8