Cleared Traditional

K960544 - CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM

K960544 is an FDA 510(k) clearance for CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM, manufactured by Nasiff Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K960544 · Nasiff Assoc., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
182d
Days
Class 2
Risk

K960544 is an FDA 510(k) clearance for the CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Nasiff Assoc., Inc. (Brewerton, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 182 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 Nasiff Assoc., Inc. devices

FDA 510(k) Submission Details - K960544

510(k) Number K960544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1996
Decision Date August 07, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
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 207
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K960544.
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · Alexander Mfg. Co. · Oct 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789 · Alexander Mfg. Co. · Oct 1997
LOG-A-RYTHM MODEL 100 AND MODEL 1001
K952790 · Nian-Crae, Inc. · Oct 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
ECG MONITOR
K944262 · Fukuda Denshi USA, Inc. · May 1995