Cleared Traditional

K911615 - HOLTER 24-HOUR ECG SYSTEM

K911615 is an FDA 510(k) clearance for HOLTER 24-HOUR ECG SYSTEM, manufactured by Diagnostic Monitoring Software. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K911615 · Diagnostic Monitoring Software · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
272d
Days
Class 2
Risk

K911615 is an FDA 510(k) clearance for the HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Diagnostic Monitoring Software (Tustin, US). The FDA issued a Cleared decision on January 8, 1992 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Monitoring Software devices

FDA 510(k) Submission Details - K911615

510(k) Number K911615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date January 08, 1992
Days to Decision 272 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 286
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K911615.
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · Siemens Medical Solutions USA, Inc. · Jan 1993
CENTRA II ANALYSIS SYSTEM
K922171 · Marquette Electronics, Inc. · Dec 1992
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)
K920295 · Oxford Medilog, Inc. · Aug 1992
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K905248 · Advanced Technology Laboratories, Inc. · Feb 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · Hewlett-Packard Co. · Jan 1991
Q5000 PC WORKSTATION
K892113 · Quinton, Inc. · May 1989