Cleared Traditional

K081437 - MAC 1600 ECG ANALYSIS SYSTEM

K081437 is an FDA 510(k) clearance for MAC 1600 ECG ANALYSIS SYSTEM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K081437 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
54d
Days
Class 2
Risk

K081437 is an FDA 510(k) clearance for the MAC 1600 ECG ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on July 15, 2008 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K081437

510(k) Number K081437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date July 15, 2008
Days to Decision 54 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
71d faster than avg
Panel avg: 125d · This submission: 54d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K081437.
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
K090483 · Philips Medical Systems · Mar 2009
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · Mortara Instrument, Inc. · Dec 2008
HANDHELD ECG MONITOR, MODEL MD100
K080933 · Beijing Choice Electronic Technololgy Co., Ltd. · Sep 2008
PAGEWRITER CARDIOGRAPH
K080999 · Philips Medical Systems · May 2008
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · Welch Allyn, Inc. · Nov 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · Nihon Kohden America, Inc. · Aug 2007