Cleared Traditional

K974101 - DATEX-ENGSTROM NETWORK

K974101 is an FDA 510(k) clearance for DATEX-ENGSTROM NETWORK, manufactured by Datex-Engstrom, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K974101 · Datex-Engstrom, Inc. · Cardiovascular device
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Feb 1998
Decision
99d
Days
Class 2
Risk

K974101 is an FDA 510(k) clearance for the DATEX-ENGSTROM NETWORK. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Datex-Engstrom, Inc. (Tewksbury, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Datex-Engstrom, Inc. devices

FDA 510(k) Submission Details - K974101

510(k) Number K974101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1997
Decision Date February 06, 1998
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 81
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K974101.
CARDIO-PAGER SYSTEM
K973527 · Data Critical Corp. · Mar 1998
TS2000 MEDICAL DEVICE MONITOR
K973640 · Trincore Systems, Inc. · Mar 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
K973318 · Ortivus Us, Inc. · Feb 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · Hewlett-Packard Co. · Jan 1998
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · Marquette Electronics, Inc. · Nov 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · Marquette Electronics, Inc. · Oct 1997