Cleared Traditional

K822856 - VITALINE 2

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

FDA 510(k) Submission Details - K822856

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 - Class ,

Product Code -
Device Class -