Cleared Traditional

Perin Health System (PHD80060-2)

K252984 · Perin Health Devices, LLC · Cardiovascular

Jan 2026

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K252984 is an FDA 510(k) clearance for the Perin Health System (PHD80060-2), a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Perin Health Devices, LLC (Oklahoma City, US). The FDA issued a Cleared decision on January 22, 2026, 126 days after receiving the submission on September 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K252984 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2025
Decision Date	January 22, 2026
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910