Cleared Traditional

K863863 - CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE)

K863863 is an FDA 510(k) clearance for CARDIONOSTICS HOLTER DURA-LITE RECORDER..., manufactured by Cardionostics, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K863863 · Cardionostics, Inc. · Cardiovascular device
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Oct 1986
Decision
12d
Days
Class 2
Risk

K863863 is an FDA 510(k) clearance for the CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardionostics, Inc. (Tustin, US). The FDA issued a Cleared decision on October 15, 1986 after a review of 12 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardionostics, Inc. devices

FDA 510(k) Submission Details - K863863

510(k) Number K863863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date October 15, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
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 121
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K863863.
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 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · Del Mar Avionics · Apr 1986
MODEL MR-30 HOLTER RECORDER
K860181 · Oxford Medilog, Inc. · Feb 1986
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986