Cleared Traditional

VITALINE 2 (K822856) - FDA 510(k) Clearance

K822856 · American Heartline, Inc. · Cardiovascular device
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Jul 1983
Decision
305d
Days
-
Risk

K822856 is an FDA 510(k) clearance for the VITALINE 2.

Submitted by American Heartline, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 29, 1983 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 American Heartline, Inc. devices

Submission Details

510(k) Number K822856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date July 29, 1983
Days to Decision 305 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 125d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -