Cleared Traditional

ACU-DOT (K781672) - FDA 510(k) Clearance

K781672 · Acu-Dot Pharmaceutical Intl., Inc. · General & Plastic Surgery device
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Nov 1978
Decision
36d
Days
-
Risk

K781672 is an FDA 510(k) clearance for the ACU-DOT.

Submitted by Acu-Dot Pharmaceutical Intl., Inc. (Walker, US). The FDA issued a Cleared decision on November 8, 1978 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Acu-Dot Pharmaceutical Intl., Inc. devices

Submission Details

510(k) Number K781672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1978
Decision Date November 08, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -