Cleared Traditional

K861851 - SIEMENS-ELEMA (SICARD-P)

K861851 is an FDA 510(k) clearance for SIEMENS-ELEMA (SICARD-P), manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K861851 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
106d
Days
Class 2
Risk

K861851 is an FDA 510(k) clearance for the SIEMENS-ELEMA (SICARD-P). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on August 28, 1986 after a review of 106 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.

FDA 510(k) Submission Details - K861851

510(k) Number K861851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1986
Decision Date August 28, 1986
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
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 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K861851.
SPACELABS SERIES 90700 PATIENT MONITORS
K862951 · Spacelabs, Inc. · Sep 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · Nihon Kohden America, Inc. · Sep 1986
BURDICK DIVISION (E-500)
K861850 · Mortara Instrument, Inc. · Aug 1986
CIRCADIAN STRESS TEST SYSTEM
K860973 · Circadian, Inc. · Aug 1986
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
K862748 · Cambridge Medical Instruments, Inc. · Aug 1986
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH
K862544 · Suzuken Co., Ltd. · Aug 1986
K861851 · SIEMENS-ELEMA (SICARD-P)
Download PDF Mortara Instrument, I…