Cleared Traditional

CREST CERVICAL TRACTION (K863838) - FDA 510(k) Clearance

K863838 · Central Equipment Sales, Inc. · Physical Medicine device
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Nov 1986
Decision
51d
Days
-
Risk

K863838 is an FDA 510(k) clearance for the CREST CERVICAL TRACTION.

Submitted by Central Equipment Sales, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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 Central Equipment Sales, Inc. devices

Submission Details

510(k) Number K863838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1986
Decision Date November 21, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -