Cleared Traditional

K854920 - THERAPY CASSETTS

K854920 · Alpha Therapeutic Corp. · Cardiovascular device
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May 1986
Decision
160d
Days
-
Risk

K854920 is an FDA 510(k) clearance for the THERAPY CASSETTS.

Submitted by Alpha Therapeutic Corp. (Rouses Point, US). The FDA issued a Cleared decision on May 19, 1986 after a review of 160 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.

View all Alpha Therapeutic Corp. devices

FDA 510(k) Submission Details - K854920

510(k) Number K854920 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 10, 1985
Decision Date May 19, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

MCU Device Classification - Class ,

Product Code MCU
Device Class -