Cleared Traditional

GOODLEY POLYAXIAL CERVICAL TRACTION UNIT (K854248) - FDA 510(k) Clearance

K854248 · E-Z-Em, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
25d
Days
-
Risk

K854248 is an FDA 510(k) clearance for the GOODLEY POLYAXIAL CERVICAL TRACTION UNIT.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 15, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K854248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date November 15, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -