Cleared Traditional

K822626 - ATC BIOELECTROGRAPHIC MONITOR MODEL I. (FDA 510(k) Clearance)

K822626 · Advantage Medical Systems, Inc. · Obstetrics & Gynecology device
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Sep 1982
Decision
13d
Days
-
Risk

K822626 is an FDA 510(k) clearance for the ATC BIOELECTROGRAPHIC MONITOR MODEL I..

Submitted by Advantage Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology 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: 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 Advantage Medical Systems, Inc. devices

Submission Details

510(k) Number K822626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1982
Decision Date September 15, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 160d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -