Cleared Traditional

K971038 - KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE

K971038 is an FDA 510(k) clearance for KONTRON KOLORMON PLUS ECG WITH RESPIRAT..., manufactured by Kontron Instruments , Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K971038 · Kontron Instruments , Ltd. · Cardiovascular device
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Sep 1997
Decision
188d
Days
Class 2
Risk

K971038 is an FDA 510(k) clearance for the KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Kontron Instruments , Ltd. (Watford, Herts, GB). The FDA issued a Cleared decision on September 24, 1997 after a review of 188 days - an extended review cycle.

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.

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FDA 510(k) Submission Details - K971038

510(k) Number K971038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date September 24, 1997
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K971038.
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
K973437 · Hewlett-Packard GmbH · Dec 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · Alexander Mfg. Co. · Oct 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · Marquette Electronics, Inc. · Sep 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc. · Aug 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · Instromedix, Inc. · Jul 1997