Cleared Traditional

K182553 - Inno-Pathwire

K182553 is the FDA 510(k) clearance for Inno-Pathwire by Suzhou Innomed Medical Device Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K182553 · Suzhou Innomed Medical Device Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
175d
Days
Class 2
Risk

K182553 is an FDA 510(k) clearance for the Inno-Pathwire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Suzhou Innomed Medical Device Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on March 11, 2019 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Suzhou Innomed Medical Device Co., Ltd. devices

Submission Details

510(k) Number K182553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date March 11, 2019
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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

Darlene Garner
Darlene Garner

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 - DQX Wire, Guide, Catheter

All 501
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