Cleared Traditional

FOOT PEDAL COVER (K860068) - FDA 510(k) Clearance

K860068 · O.R. Concepts, Inc. · General & Plastic Surgery device
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Jan 1986
Decision
21d
Days
-
Risk

K860068 is an FDA 510(k) clearance for the FOOT PEDAL COVER.

Submitted by O.R. Concepts, Inc. (Irving, US). The FDA issued a Cleared decision on January 27, 1986 after a review of 21 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 O.R. Concepts, Inc. devices

Submission Details

510(k) Number K860068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 27, 1986
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -