Cleared Traditional

K894285 - DMI PC HOLTER SCANNER

K894285 is an FDA 510(k) clearance for DMI PC HOLTER SCANNER, manufactured by Diagnostic Medical Instruments. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K894285 · Diagnostic Medical Instruments · Cardiovascular device
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Sep 1989
Decision
95d
Days
Class 2
Risk

K894285 is an FDA 510(k) clearance for the DMI PC HOLTER SCANNER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Diagnostic Medical Instruments (Syracuse, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 95 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 Diagnostic Medical Instruments devices

FDA 510(k) Submission Details - K894285

510(k) Number K894285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date September 26, 1989
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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 311
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K894285.
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · Fukuda Denshi USA, Inc. · Jan 1990
1100 VITAL SIGNS MONITOR
K884643 · Criticare Systems, Inc. · Oct 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · Nihon Kohden America, Inc. · Oct 1989
SEER
K882818 · Marquette Electronics, Inc. · Jun 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323 · Marquette Electronics, Inc. · Jun 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148 · Del Mar Avionics · May 1989