Cleared Traditional

K874313 - MODEL 492 SSR (TM) RECORDER

K874313 is an FDA 510(k) clearance for MODEL 492 SSR (TM) RECORDER, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K874313 · Del Mar Avionics · Cardiovascular device
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Feb 1988
Decision
125d
Days
Class 2
Risk

K874313 is an FDA 510(k) clearance for the MODEL 492 SSR (TM) RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on February 22, 1988 after a review of 125 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K874313

510(k) Number K874313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date February 22, 1988
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 194
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K874313.
POLYCORD II
K880303 · Technetics, Inc. · Dec 1988
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · Del Mar Avionics · Nov 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · Brentwood Instruments, Inc. · Aug 1988
PATIENTWATCH (TM)
K874571 · Advanced Medical Technology, Inc. · Jan 1988
MODEL SSR1 HOLTER MONITOR
K873337 · Cardiodata Corp. · Oct 1987
MODEL MICRO FD+ AMBULATORY ECG MONITOR
K872508 · Advanced Medical Products, Inc. · Sep 1987
K874313 · MODEL 492 SSR (TM) RECORDER
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