Cleared Traditional

K030316 - AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)

K030316 is an FDA 510(k) clearance for AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR), manufactured by Inovise Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K030316 · Inovise Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
189d
Days
Class 2
Risk

K030316 is an FDA 510(k) clearance for the AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Newberg, US). The FDA issued a Cleared decision on August 7, 2003 after a review of 189 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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 - K030316

510(k) Number K030316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2003
Decision Date August 07, 2003
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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.
JOHN SO

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 - DRX Electrode, Electrocardiograph

All 215
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K030316.
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