Cleared Traditional

K974510 - ENVOY PATIENT MONITOR

K974510 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 DSI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K974510 · Mennen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
134d
Days
Class 2
Risk

K974510 is an FDA 510(k) clearance for the ENVOY PATIENT MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Rehovot, IL). The FDA issued a Cleared decision on April 14, 1998 after a review of 134 days - within the typical 510(k) review window.

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. 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 Mennen Medical, Inc. devices

FDA 510(k) Submission Details - K974510

510(k) Number K974510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1997
Decision Date April 14, 1998
Days to Decision 134 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
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 305
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K974510.
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502 · Spacelabs Medical, Inc. · May 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747 · Datex-Engstrom, Inc. · Apr 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910 · Hewlett-Packard GmbH · Mar 1998
OBSERVER * CENTRAL STATION
K972498 · Johnson & Johnson Medical, Inc. · Feb 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358 · Mennen Medical, Inc. · Feb 1998