Cleared Traditional

K822818 - HOLTER RECORDER & PLAYBACK/ANALYSIS SYS

K822818 is an FDA 510(k) clearance for HOLTER RECORDER & PLAYBACK/ANALYSIS SYS, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K822818 · Marquette Electronics, Inc. · Cardiovascular device
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Dec 1982
Decision
101d
Days
Class 2
Risk

K822818 is an FDA 510(k) clearance for the HOLTER RECORDER & PLAYBACK/ANALYSIS SYS. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 101 days - within the typical 510(k) review window.

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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K822818

510(k) Number K822818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1982
Decision Date December 30, 1982
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 118
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K822818.
ELECTROCARDIOCORDER RECORDER 453
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OMAR
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CARDIOCASSETTE II #363
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CASSETTE READER
K811253 · American Edwards Laboratories · Jul 1981