Cleared Traditional

K052637 - THEROX INFUSION CATHETER, MODEL INCA-1

K052637 is an FDA 510(k) clearance for THEROX INFUSION CATHETER, manufactured by Therox, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K052637 · Therox, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
163d
Days
Class 2
Risk

K052637 is an FDA 510(k) clearance for the THEROX INFUSION CATHETER, MODEL INCA-1. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Therox, Inc. (Irvine, US). The FDA issued a Cleared decision on March 8, 2006 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 - K052637

510(k) Number K052637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date March 08, 2006
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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

Underwriters Laboratories, Inc.

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 - DQO Catheter, Intravascular, Diagnostic

All 449
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K052637.
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
K052908 · Infraredx, Inc. · Jun 2006
MICRUS COURIER MICROCATHETERS
K060116 · Micrus Endovascular Corporation · May 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · Boston Scientific Corp · Mar 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
K053171 · Merit Medical Systems, Inc. · Jan 2006
HOSPIRA CATH LAB CONVENIENCE KITS
K052865 · Icu Medical, Inc. · Dec 2005
ASAHI ANGIOGRAPHIC CATHETER
K051561 · Asahi Intecc Co., Ltd. · Nov 2005
K052637 · THEROX INFUSION CATHETER, MODEL INCA-1
Download PDF FDA Summary Therox, Inc.