Cleared Traditional

K243837 - iBSM

K243837 is an FDA 510(k) clearance for iBSM, manufactured by Iorbit Digital Technologies Private Limited. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K243837 · Iorbit Digital Technologies Private Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
154d
Days
Class 2
Risk

K243837 is an FDA 510(k) clearance for the iBSM. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Iorbit Digital Technologies Private Limited (Bangalore, IN). The FDA issued a Cleared decision on May 16, 2025 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Iorbit Digital Technologies Private Limited devices

FDA 510(k) Submission Details - K243837

510(k) Number K243837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 73
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K243837.
Perin Health System (PHD80060-2)
K252984 · Perin Health Devices, LLC · Jan 2026
EasyTeleMed (2.0.2)
K252440 · Ingeniars S.R.L. · Oct 2025
TeleRehab Aermos Cardiopulmonary Rehabilitation
K250259 · The ScottCare Corporation · Jun 2025
UbiqVue™ 2A Multi-parameter System (UX2550)
K242018 · Lifesignals, Inc. · Nov 2024
BioButton System
K241101 · Biointellisense, Inc. · Sep 2024
ANNE Chest
K240251 · Sibel Health, Inc. · Jun 2024