Cleared Traditional

K150095 - ReDs Wearable System

K150095 is the FDA 510(k) clearance for ReDs Wearable System by Sensible Medical Innovations , Ltd.. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K150095 · Sensible Medical Innovations , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
202d
Days
Class 2
Risk

K150095 is an FDA 510(k) clearance for the ReDs Wearable System. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Sensible Medical Innovations , Ltd. (Netanya, IL). The FDA issued a Cleared decision on August 6, 2015 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Sensible Medical Innovations , Ltd. devices

Submission Details

510(k) Number K150095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2015
Decision Date August 06, 2015
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 17
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K150095.
Cardiac Monitor 1500
K191697 · Zynex Medical, Inc. · Feb 2020
ReDS System
K180479 · Sensible Medical Innovations , Ltd. · Feb 2019
Cardiovascular Analzyer
K172431 · Physiowave, Inc. · Mar 2018
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · Conmed Corporation · Dec 2013
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004
ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001