Cleared Traditional

DURAN FLEXIBLE RING (K780568) - FDA 510(k) Clearance

K780568 · Hancock Laboratories, Inc. · Cardiovascular device
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May 1978
Decision
46d
Days
-
Risk

K780568 is an FDA 510(k) clearance for the DURAN FLEXIBLE RING.

Submitted by Hancock Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 46 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 Hancock Laboratories, Inc. devices

Submission Details

510(k) Number K780568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date May 26, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -