Cleared Traditional

K840869 - SURGICAL MODULE 7000 ECG

K840869 is an FDA 510(k) clearance for SURGICAL MODULE 7000 ECG, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K840869 · Marquette Electronics, Inc. · Cardiovascular device
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Feb 1985
Decision
345d
Days
Class 2
Risk

K840869 is an FDA 510(k) clearance for the SURGICAL MODULE 7000 ECG. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K840869

510(k) Number K840869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date February 06, 1985
Days to Decision 345 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 125d · This submission: 345d
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 437
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K840869.
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985
CARDIO-NEC MODEL 365
K844101 · Birtcher Corp. · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
CARDIO IV/GXT STRESS TESTING SYSTEM
K844744 · Intl. Medical, Inc. · Jan 1985
FUKUDA DENSHI MODEL FCP-220
K844470 · Brentwood Instruments, Inc. · Jan 1985
FITNESS LOGGER
K840020 · Britt Corp., Inc. · Oct 1984