Cleared Abbreviated

K990027 - OMNICORDER, MODEL 464

K990027 is an FDA 510(k) clearance for OMNICORDER, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Abbreviated 510(k) pathway after a 35-day FDA review.

K990027 · Del Mar Avionics · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
35d
Days
Class 2
Risk

K990027 is an FDA 510(k) clearance for the OMNICORDER, MODEL 464. 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 9, 1999 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K990027

510(k) Number K990027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1999
Decision Date February 09, 1999
Days to Decision 35 days
Submission Type Abbreviated
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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

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 K990027.
DR180+OXY
K004007 · North East Monitoring, Inc. · Jan 2001
LIFECARD CF COMPACT RECORDER
K001025 · Reynolds Medical , Ltd. · Apr 2000
CARDIOLIGHT
K982448 · Capintec, Inc. · Jun 1999
MERCATOR
K982384 · Harley Street Software , Ltd. · Jan 1999
MICROVIT MT-100
K973735 · Schiller America, Inc. · Aug 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION
K974420 · Hewlett-Packard Co. · Feb 1998
K990027 · OMNICORDER, MODEL 464
Download PDF FDA Summary Del Mar Avionics