Cleared Traditional

K871389 - HOLTER ST SYSTEM, MODEL NO. 5000-20

K871389 is an FDA 510(k) clearance for HOLTER ST SYSTEM, manufactured by Holter Data Services. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K871389 · Holter Data Services · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
147d
Days
Class 2
Risk

K871389 is an FDA 510(k) clearance for the HOLTER ST SYSTEM, MODEL NO. 5000-20. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Holter Data Services (Tustin, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 147 days - within the typical 510(k) review window.

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. 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 Holter Data Services devices

FDA 510(k) Submission Details - K871389

510(k) Number K871389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date September 01, 1987
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 125d · This submission: 147d
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 313
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K871389.
EPICARIDA, LE
K872837 · Medicomp, Inc. · Nov 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497 · Oxford Medilog, Inc. · Oct 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · Fukuda Denshi USA, Inc. · Mar 1987
CARDIOFAX-V ECG-8240A
K865030 · Nihon Kohden America, Inc. · Mar 1987
CARDIOFAX-V ECG-834OA
K865032 · Nihon Kohden America, Inc. · Mar 1987