Cleared Traditional

K851489 - ARTERIAL-VENOUS COMPRESSION DRESSING (FDA 510(k) Clearance)

K851489 · Medi-Plast Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
57d
Days
-
Risk

K851489 is an FDA 510(k) clearance for the ARTERIAL-VENOUS COMPRESSION DRESSING.

Submitted by Medi-Plast Intl., Inc. (Atlanta, US). The FDA issued a Cleared decision on June 11, 1985 after a review of 57 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 Medi-Plast Intl., Inc. devices

Submission Details

510(k) Number K851489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date June 11, 1985
Days to Decision 57 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
57d faster than avg
Panel avg: 114d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -