Cleared Traditional

K854269 - MODEL 509A PHYSIOCORDER AMBULATORY RECORDER

K854269 is an FDA 510(k) clearance for MODEL 509A PHYSIOCORDER AMBULATORY 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 170-day FDA review.

K854269 · Del Mar Avionics · Cardiovascular device
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Apr 1986
Decision
170d
Days
Class 2
Risk

K854269 is an FDA 510(k) clearance for the MODEL 509A PHYSIOCORDER AMBULATORY 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 April 11, 1986 after a review of 170 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K854269

510(k) Number K854269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date April 11, 1986
Days to Decision 170 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
45d slower than avg
Panel avg: 125d · This submission: 170d
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 112
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K854269.
MODEL 492 SSR (TM) RECORDER
K874313 · Del Mar Avionics · Feb 1988
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · Medtronic Vascular · Jul 1987
NIGHTWATCH(TM) SYSTEM
K870578 · Buckman Co., Inc. · Jun 1987
MODEL MR-30 HOLTER RECORDER
K860181 · Oxford Medilog, Inc. · Feb 1986
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986
SERIES 7000/HOLTER RECORDER
K851971 · Pfizer, Inc. · Jun 1985