Cleared Traditional

K173589 - Prizma

K173589 is the FDA 510(k) clearance for Prizma by G-Medical Innovations , Ltd.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K173589 · G-Medical Innovations , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
375d
Days
Class 2
Risk

K173589 is an FDA 510(k) clearance for the Prizma. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by G-Medical Innovations , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on November 30, 2018 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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.

View all G-Medical Innovations , Ltd. devices

Submission Details

510(k) Number K173589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2017
Decision Date November 30, 2018
Days to Decision 375 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
250d slower than avg
Panel avg: 125d · This submission: 375d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03340441 Unknown Observational Industry-sponsored

Prizma Device Temperature Measurement

Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application

300
Patients (est.)
1
Site
Condition studied Temperature Change, Body
Eligibility All sexes · 17 Years+
Principal investigator Moshe Tishler, Prof.
Sponsor G Medical Innovations Ltd. (industry)
Started 2017-04-19 → Primary completion 2017-12-01 → Completed 2017-12-30
Primary outcome
Temperature measurement
View full study on ClinicalTrials.gov

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 92
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K173589.
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704 · Vivaquant, Inc. · Feb 2019
Coala Heart Monitor
K182040 · Coala Life AB · Feb 2019
Study Watch
K182456 · Verily Life Sciences, LLC · Jan 2019
FibriCheck
K173872 · Qompium NV · Sep 2018
CARDIOSKIN
K173248 · Bioserenity Sas · Aug 2018
QT ECG
K180157 · QT Medical, Inc. · May 2018