Cleared Traditional

K770124 - PRE-ROLLED IMPERVIOUS STOCKINETTE (FDA 510(k) Clearance)

K770124 · National Patent Development Corp. · Orthopedic device
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Jan 1977
Decision
5d
Days
-
Risk

K770124 is an FDA 510(k) clearance for the PRE-ROLLED IMPERVIOUS STOCKINETTE.

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1977 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 National Patent Development Corp. devices

Submission Details

510(k) Number K770124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1977
Decision Date January 26, 1977
Days to Decision 5 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 122d · This submission: 5d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -