Cleared Traditional

K132148 - S HEALTH

K132148 is an FDA 510(k) clearance for S HEALTH, manufactured by Samsung Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K132148 · Samsung Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
146d
Days
Class 2
Risk

K132148 is an FDA 510(k) clearance for the S HEALTH. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Samsung Electronics Co., Ltd. (Suwon-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on December 4, 2013 after a review of 146 days - within the typical 510(k) review window.

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 Samsung Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K132148

510(k) Number K132148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2013
Decision Date December 04, 2013
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 134
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K132148.
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
K134004 · Cellco Partnership D/B/A Verizon Wireless · Feb 2014
PRESSUREWIRE AERIS AGILE TIP
K133587 · St. Jude Medical Systems AB · Dec 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803 · Medapps Inc., Dba Alere Connect · Dec 2013
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
K131913 · Philips Medizin Systeme Boeblingen GmbH · Nov 2013
OPTUM TELEHEALTH APPLICATION
K130971 · Optumhealth Care Solutions, Inc. · Oct 2013
INTEL-GE CARE INNOVATIONS CONNECT RCM
K130821 · Intel-Ge Care Innovations, LLC · Aug 2013