Cleared Traditional

K851044 - CARDIOSTAT 3 RECORDER

K851044 is an FDA 510(k) clearance for CARDIOSTAT 3 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 104-day FDA review.

K851044 · Siemens Elema AB · Cardiovascular device
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Jun 1985
Decision
104d
Days
Class 2
Risk

K851044 is an FDA 510(k) clearance for the CARDIOSTAT 3 RECORDER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 104 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 - K851044

510(k) Number K851044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1985
Decision Date June 26, 1985
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K851044.
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · Medical Data Electronics · Jan 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
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