Cleared Traditional

SIEMENS CARDIOSTAT 701 (K790794) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K790794 · Elmed, Inc. · Cardiovascular device
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May 1979
Decision
37d
Days
Class 2
Risk

K790794 is an FDA 510(k) clearance for the SIEMENS CARDIOSTAT 701. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Elmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1979 after a review of 37 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 Elmed, Inc. devices

Submission Details

510(k) Number K790794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date May 31, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K790794.
ELECTROCARDIOGRAPH MODEL ECG-5403
K791540 · Nihon Kohden America, Inc. · Sep 1979
QUINTON MODEL 630 AND 636 ECG DATA CART
K791364 · Quinton, Inc. · Aug 1979
MODEL 78501A PATIENT MONITORING SYSTEM
K790939 · Hewlett-Packard Co. · Jun 1979
QUINTON MODEL 530X ECG DATA CART
K790739 · Quinton, Inc. · Apr 1979
STRESS TEST SYSTEM
K780166 · Quinton, Inc. · Feb 1978
ELAPSED TIME INDICATOR MODEL 21361A
K771380 · Hewlett-Packard Co. · Nov 1977