Cleared Traditional

CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID (K860555) - FDA 510(k) Clearance

K860555 · Auralogic · Cardiovascular device
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Feb 1986
Decision
7d
Days
-
Risk

K860555 is an FDA 510(k) clearance for the CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID.

Submitted by Auralogic (Norwalk, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Auralogic devices

Submission Details

510(k) Number K860555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date February 21, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -