Cleared Traditional

RADIOEAR MODEL 1072 (K770402) - FDA 510(k) Clearance

K770402 · Radioear Corp. · Gastroenterology & Urology device
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Mar 1977
Decision
7d
Days
-
Risk

K770402 is an FDA 510(k) clearance for the RADIOEAR MODEL 1072.

Submitted by Radioear Corp. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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 Radioear Corp. devices

Submission Details

510(k) Number K770402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1977
Decision Date March 10, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 130d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -