Cleared Traditional

K160121 - CorPath GRX System

K160121 is an FDA 510(k) clearance for CorPath GRX System, manufactured by Corindus, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K160121 · Corindus, Inc. · Cardiovascular device
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Oct 2016
Decision
282d
Days
Class 2
Risk

K160121 is an FDA 510(k) clearance for the CorPath GRX System. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Corindus, Inc. (Waltham, US). The FDA issued a Cleared decision on October 27, 2016 after a review of 282 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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 Corindus, Inc. devices

FDA 510(k) Submission Details - K160121

510(k) Number K160121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date October 27, 2016
Days to Decision 282 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
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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

CardioMed Device Consultants, LLC
Mona Advani

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.

Regulatory Peers - DXX System, Catheter Control, Steerable

All 31
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K160121.
CorPath GRX System
K180517 · Corindus, Inc. · Mar 2018
CorPath GRX System
K173806 · Corindus, Inc. · Mar 2018
CorPath GRX System
K173288 · Corindus, Inc. · Feb 2018
CorPath 200 System
K152999 · Corindus, Inc. · Mar 2016
CorPath 200 System
K150892 · Corindus, Inc. · Oct 2015
Magellan Robotic System
K151730 · Hansen Medical, Inc. · Jul 2015