Cleared Traditional

K944262 - ECG MONITOR

K944262 is an FDA 510(k) clearance for ECG MONITOR, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K944262 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
255d
Days
Class 2
Risk

K944262 is an FDA 510(k) clearance for the ECG MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Great Neck,, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 255 days - an extended review cycle.

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 Fukuda Denshi USA, Inc. devices

FDA 510(k) Submission Details - K944262

510(k) Number K944262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1994
Decision Date May 12, 1995
Days to Decision 255 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
130d slower than avg
Panel avg: 125d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 217
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K944262.
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
K960544 · Nasiff Assoc., Inc. · Aug 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688 · Safety Tek Corp. · Apr 1996
EAGLE 3000 PATIENT MONITOR
K952474 · Marquette Electronics, Inc. · Oct 1995
MERCURY
K940081 · Mennen Medical, Inc. · Apr 1995
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257 · Bio-Tek Instruments, Inc. · Sep 1994
ESCORT 100/300 SERIES B PATIENT MONITORS
K930004 · Medical Data Electronics · Jun 1993