Cleared Traditional

K970298 - DM-400 HOLTER ECG CASSETTE RECORDER

K970298 is an FDA 510(k) clearance for DM-400 HOLTER ECG CASSETTE RECORDER, manufactured by Diagnostic Monitoring. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K970298 · Diagnostic Monitoring · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
205d
Days
Class 2
Risk

K970298 is an FDA 510(k) clearance for the DM-400 HOLTER ECG CASSETTE RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Diagnostic Monitoring (Santa Ana, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 205 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 devices

FDA 510(k) Submission Details - K970298

510(k) Number K970298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date August 20, 1997
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 93
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K970298.
OMNICORDER, MODEL 464
K990027 · Del Mar Avionics · Feb 1999
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420 · Hewlett-Packard Co. · Feb 1998
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
K971670 · Galix Biomedical Instrumentation, Inc. · Jan 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · Alexander Mfg. Co. · Jul 1997
MEDILOG FD4
K970902 · Oxford Instruments Medical Systems · May 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · Del Mar Avionics · Mar 1997