Cleared Traditional

K001120 - ENVOY PATIENT MONITOR

K001120 is an FDA 510(k) clearance for ENVOY PATIENT MONITOR, manufactured by Mennen Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K001120 · Mennen Medical , Ltd. · Cardiovascular device
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May 2001
Decision
396d
Days
Class 2
Risk

K001120 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 , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on May 8, 2001 after a review of 396 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 , Ltd. devices

FDA 510(k) Submission Details - K001120

510(k) Number K001120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date May 08, 2001
Days to Decision 396 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
271d slower than avg
Panel avg: 125d · This submission: 396d
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 257
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K001120.
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
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MODIFICATION TO ENVOY PATIENT MONITOR
K011784 · Mennen Medical , Ltd. · Aug 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824 · Agilent Technologies, Inc. · Jul 2001
ORG-9200A
K002068 · Nihon Kohden America, Inc. · Feb 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · Quinton, Inc. · Jan 2001
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · Siemens Medical Solutions USA, Inc. · Dec 2000