Cleared Traditional

K822363 - ALTA III ECG RECORDER

K822363 is an FDA 510(k) clearance for ALTA III ECG RECORDER, manufactured by Scole Engineering Co.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K822363 · Scole Engineering Co. · Cardiovascular device
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Oct 1982
Decision
59d
Days
Class 2
Risk

K822363 is an FDA 510(k) clearance for the ALTA III ECG RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Scole Engineering Co. (Walker, US). The FDA issued a Cleared decision on October 4, 1982 after a review of 59 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 Scole Engineering Co. devices

FDA 510(k) Submission Details - K822363

510(k) Number K822363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1982
Decision Date October 04, 1982
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 K822363.
OMAR
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HOLTER KIT MODEL #5000 SERIES
K823414 · Andover Medical, Inc. · Dec 1982
CARDIOCASSETTE II #363
K821453 · Birtcher Corp. · May 1982
CASSETTE READER
K811253 · American Edwards Laboratories · Jul 1981
ADVANCEMED CCU DOCUMENTOR
K803222 · American Edwards Laboratories · Jan 1981