Cleared Traditional

K133997 - LG SMARTHEALTH (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133997 · Lg Electronics · Cardiovascular device
Nov 2014
Decision
329d
Days
Class 2
Risk

K133997 is an FDA 510(k) clearance for the LG SMARTHEALTH. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Lg Electronics (Austin, US). The FDA issued a Cleared decision on November 21, 2014 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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

Submission Details

510(k) Number K133997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2013
Decision Date November 21, 2014
Days to Decision 329 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K133997.
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
iBSM
K243837 · Iorbit Digital Technologies Private Limited · May 2025