Cleared Traditional

MARK 500 SYSTEM (K812416) - FDA 510(k) Clearance

K812416 · Kallestad Laboratories, Inc. · Obstetrics & Gynecology device
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Apr 1982
Decision
227d
Days
-
Risk

K812416 is an FDA 510(k) clearance for the MARK 500 SYSTEM.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K812416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1981
Decision Date April 08, 1982
Days to Decision 227 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
67d slower than avg
Panel avg: 160d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -