Cleared Traditional

THERAPY CASSETTS (K854920) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code MCU
Device Class -