Cleared Traditional

K012686 - CAIRD TECHNOLOGY HOLTER 2000

K012686 is an FDA 510(k) clearance for CAIRD TECHNOLOGY HOLTER 2000, manufactured by Caird Technology. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K012686 · Caird Technology · Cardiovascular device
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Dec 2001
Decision
121d
Days
Class 2
Risk

K012686 is an FDA 510(k) clearance for the CAIRD TECHNOLOGY HOLTER 2000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Caird Technology (Columbia, US). The FDA issued a Cleared decision on December 13, 2001 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K012686

510(k) Number K012686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date December 13, 2001
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 491
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K012686.
COSMED QUARK C12/QUARK T12
K014262 · Cosmed Srl · Mar 2002
PRIME ECG SYSTEM
K012414 · Meridian Medical Technologies, Inc. · Mar 2002
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
K013717 · Brentwood Medical Technology Corp. · Feb 2002
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · Reynolds Medical , Ltd. · Dec 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc. · Nov 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · Cambridge Heart, Inc. · Nov 2001
K012686 · CAIRD TECHNOLOGY HOLTER 2000
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