Cleared Traditional

K844392 - CARDIOSTAT 1 ECG RECORDER

K844392 is an FDA 510(k) clearance for CARDIOSTAT 1 ECG RECORDER, manufactured by Siemens Elema AB. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K844392 · Siemens Elema AB · Cardiovascular device
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Apr 1985
Decision
149d
Days
Class 2
Risk

K844392 is an FDA 510(k) clearance for the CARDIOSTAT 1 ECG RECORDER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Siemens Elema AB (Chicago, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 149 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.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K844392

510(k) Number K844392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date April 11, 1985
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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 275
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K844392.
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · Medical Data Electronics · Jan 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
CARDIO-NEC MODEL 365
K844101 · Birtcher Corp. · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985