Cleared Traditional

K864816 - CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE (FDA 510(k) Clearance)

K864816 · Currie Medical Specialties, Inc. · General & Plastic Surgery device
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Jan 1987
Decision
30d
Days
-
Risk

K864816 is an FDA 510(k) clearance for the CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE.

Submitted by Currie Medical Specialties, Inc. (Monrovia, US). The FDA issued a Cleared decision on January 8, 1987 after a review of 30 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 Currie Medical Specialties, Inc. devices

Submission Details

510(k) Number K864816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date January 08, 1987
Days to Decision 30 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
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -