Cleared Traditional

K944262 - ECG MONITOR (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 337
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