Cleared Traditional

K160656 - CorSens

K160656 is an FDA 510(k) clearance for CorSens, manufactured by Corsens Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code DXR cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K160656 · Corsens Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
258d
Days
Class 2
Risk

K160656 is an FDA 510(k) clearance for the CorSens. Classified as Ballistocardiograph (product code DXR), Class II - Special Controls.

Submitted by Corsens Medical , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on November 21, 2016 after a review of 258 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2320 - 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.

FDA 510(k) Submission Details - K160656

510(k) Number K160656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2016
Decision Date November 21, 2016
Days to Decision 258 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
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXR Device Classification - Class 2, Special Controls

Product Code DXR Ballistocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2320
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 Consultant

Qsite
Yoram Levy

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.

K160656 · CorSens
Download PDF FDA Summary Corsens Medical , Ltd.