Cleared Traditional

K942781 - DIGITAL HOLTER RECORDER

K942781 is an FDA 510(k) clearance for DIGITAL HOLTER RECORDER, manufactured by Agilent Technologies. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K942781 · Agilent Technologies · Cardiovascular device
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Jan 1995
Decision
225d
Days
Class 2
Risk

K942781 is an FDA 510(k) clearance for the DIGITAL HOLTER RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Agilent Technologies (Camarillo, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 225 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.

FDA 510(k) Submission Details - K942781

510(k) Number K942781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date January 24, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 125d · This submission: 225d
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 144
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K942781.
SONICAID MODEL MR-63 AMBULATORY ECG RECORDER
K943862 · Oxford Instruments Medical Systems · Jun 1995
HOLTER SSR DIGICORDER(TM)
K942653 · Del Mar Avionics · May 1995
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
K945130 · Braemar Corp. · Apr 1995
HEARTPRINT
K942862 · Medata, Inc. · Jan 1995
TRACKER 2/TRACKER 3 HOLTER RECORDER
K943278 · Reynolds Medical , Ltd. · Oct 1994
ALTAIR 6100 CASSETTE RECORDER
K942438 · Burdick, Inc. · Aug 1994
K942781 · DIGITAL HOLTER RECORDER
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