Cleared Traditional

K073545 - AUDICOR, HEMO AMBULATORY MONITOR (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073545 · Inovise Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
266d
Days
Class 2
Risk

K073545 is an FDA 510(k) clearance for the AUDICOR, HEMO AMBULATORY MONITOR. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Inovise Medical, Inc. (Portland, US). The FDA issued a Cleared decision on September 9, 2008 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Inovise Medical, Inc. devices

Submission Details

510(k) Number K073545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date September 09, 2008
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 Peers - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 58
Devices cleared under the same product code (MWJ) and FDA review panel - the closest regulatory comparables to K073545.
HeartBeam AIMIGo(TM) System
K231424 · Heartbeam, Inc. · Dec 2024
ASSURE Wearable ECG
K233864 · Kestra Medical Technologies, Inc. · May 2024
Eclipse MINI Model 98900
K212317 · Spacelabs Healthcare, Ltd. · Nov 2022
Biotres
K222017 · Biotricity · Jul 2022
Q Patch
K210758 · Medicalgorithmics S.A. · Jun 2022
Biotres
K211709 · Biotricity · Jan 2022