Cleared Traditional

K920294 - SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM (FDA 510(k) Clearance)

K920294 · Stuart Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
167d
Days
-
Risk

K920294 is an FDA 510(k) clearance for the SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM.

Submitted by Stuart Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 7, 1992 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. 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.

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Submission Details

510(k) Number K920294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date July 07, 1992
Days to Decision 167 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -