Cleared Traditional

K822362 - ALTA II ECG RECORDER

K822362 is an FDA 510(k) clearance for ALTA II 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 161-day FDA review.

K822362 · Scole Engineering Co. · Cardiovascular device
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Jan 1983
Decision
161d
Days
Class 2
Risk

K822362 is an FDA 510(k) clearance for the ALTA II 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 January 14, 1983 after a review of 161 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.

View all Scole Engineering Co. devices

FDA 510(k) Submission Details - K822362

510(k) Number K822362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1982
Decision Date January 14, 1983
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 K822362.
ELECTROCARDIOCORDER RECORDER 453
K833661 · Del Mar Avionics · Nov 1983
AMBULATORY ECG EVENT RECORDER
K830907 · Brentwood Instruments, Inc. · Jul 1983
OMAR
K830915 · Oxford Medilog, Inc. · Jul 1983
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · Andover Medical, Inc. · Dec 1982
CARDIOCASSETTE II #363
K821453 · Birtcher Corp. · May 1982