510(k) Report

FDA applicant

Recor Medical, Inc.

Palo Alto1 decision2023–20232 recalls

FDA records 1 decision for Recor Medical, Inc. (Palo Alto) in 2023: 1 original PMA approval. All are in product code QYI (Ablation Catheter, Renal Denervation). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2023high 2 (2026) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Recor Medical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QYIAblation Catheter, Renal Denervation1decision

What has FDA decided for it lately?

  • P220023Paradise® Ultrasound Renal Denervation SystemRecor Medical, Inc. · 20232 recalls

The one decision as Recor Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P220023Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿…Jan 29, 2026Class II
  • P220023Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿…Jan 29, 2026Class II