510(k) Report

FDA applicant

Renascence Medical, Inc.

Bloomington, IN1 decision2005–20050 recalls

FDA records 1 decision for Renascence Medical, Inc. (Bloomington, IN) in 2005: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Renascence Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Renascence Medical, 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?

  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K052658Selectflow - Intravascular Administration SetRenascence Medical, Inc. · 2005

The one decision as Renascence Medical, Inc. →