510(k) Report

FDA applicant

Cryoptherapy Pain Relief Products, Inc.

Pembroke Pines, FL1 decision1998–19980 recalls

FDA records 1 decision for Cryoptherapy Pain Relief Products, Inc. (Pembroke Pines, FL) in 1998: 1 510(k) clearance. All are in product code LKX (Device, Thermal, Hemorrhoids). No recall is linked to its devices.

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

How often FDA has decided Cryoptherapy Pain Relief Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cryoptherapy Pain Relief Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cryoptherapy Pain Relief Products, 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?

  • LKXDevice, Thermal, Hemorrhoids1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K981428Anu IceCryoptherapy Pain Relief Products, Inc. · 19983cite it

What has FDA decided for it lately?

  • K981428Anu IceCryoptherapy Pain Relief Products, Inc. · 1998

The one decision as Cryoptherapy Pain Relief Products, Inc. →