Cleared Traditional

iBSM

K243837 · Iorbit Digital Technologies Private Limited · Cardiovascular

May 2025

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K243837 is an FDA 510(k) clearance for the iBSM, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Iorbit Digital Technologies Private Limited (Bangalore, IN). The FDA issued a Cleared decision on May 16, 2025, 154 days after receiving the submission on December 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K243837 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2024
Decision Date	May 16, 2025
Days to Decision	154 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