Cleared Traditional

K030722 - ENVOY PATIENT MONITOR

K030722 is an FDA 510(k) clearance for ENVOY PATIENT MONITOR, manufactured by Mennen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K030722 · Mennen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
356d
Days
Class 2
Risk

K030722 is an FDA 510(k) clearance for the ENVOY PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Rehovot, IL). The FDA issued a Cleared decision on February 26, 2004 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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. Elevated predicate reliance profile. 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 Mennen Medical, Inc. devices

FDA 510(k) Submission Details - K030722

510(k) Number K030722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2003
Decision Date February 26, 2004
Days to Decision 356 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
231d slower than avg
Panel avg: 125d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 409
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K030722.
INFINITY MODULAR MONITORS VF4 MODIFICATIONS
K033694 · Draeger Medical Systems, Inc. · Mar 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
K040357 · Philips Medical Systems, Inc. · Mar 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · Philips Medizin Systeme Boeblingen GmbH · Mar 2004
SOLAR 9500 INFORMATION MONITOR
K033964 · Ge Medical Systems Information Technologies · Jan 2004
INFINITY GAMMAXL
K033600 · Draeger Medical Systems, Inc. · Dec 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · Datex-Ohmeda, Inc. · Dec 2003