Cleared Traditional

K842954 - CARDIONOSTICS HOLTER DURA-LITE RECORDE

K842954 is an FDA 510(k) clearance for CARDIONOSTICS HOLTER DURA-LITE RECORDE, 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 39-day FDA review.

K842954 · Cardionostics, Inc. · Cardiovascular device
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Sep 1984
Decision
39d
Days
Class 2
Risk

K842954 is an FDA 510(k) clearance for the CARDIONOSTICS HOLTER DURA-LITE RECORDE. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Cardionostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 39 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 - K842954

510(k) Number K842954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date September 04, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
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 K842954.
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · Spacelabs, Inc. · Feb 1985
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · Del Mar Avionics · Dec 1984
MINGOGRAF 7
K841868 · Siemens Medical Solutions USA, Inc. · Oct 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · Aequitron Medical, Inc. · Apr 1984
EVENT TAPE RECORDER 8293
K833349 · Aequitron Medical, Inc. · Apr 1984
ELECTROCARDIOCORDER RECORDER 453
K833661 · Del Mar Avionics · Nov 1983