Cleared Traditional

CPR PROMPT (K853428) - FDA 510(k) Clearance

K853428 · Hutchins Tool & Engineering Co., Inc. · Cardiovascular device
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Sep 1985
Decision
22d
Days
-
Risk

K853428 is an FDA 510(k) clearance for the CPR PROMPT.

Submitted by Hutchins Tool & Engineering Co., Inc. (Washington, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 22 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 Hutchins Tool & Engineering Co., Inc. devices

Submission Details

510(k) Number K853428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1985
Decision Date September 06, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -