Cleared Traditional

K870816 - KONTRON STRESSDATA STRESS DATA MANAGEME...

K870816 is an FDA 510(k) clearance for KONTRON STRESSDATA STRESS DATA MANAGEME..., manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K870816 · Kontron Instruments, Inc. · Cardiovascular device
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Mar 1988
Decision
364d
Days
Class 2
Risk

K870816 is an FDA 510(k) clearance for the KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K870816

510(k) Number K870816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date March 01, 1988
Days to Decision 364 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
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 234
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K870816.
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MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
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CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
FUKUDA DENSHI MODEL FCP-231
K874768 · Fukuda Denshi USA, Inc. · Dec 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · Oxford Medilog, Inc. · Nov 1987