Cleared Traditional

ORTHO ACTIVE KNEE BRACE (K842790) - FDA 510(k) Clearance

K842790 · Ortho Active Appliances , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
9d
Days
-
Risk

K842790 is an FDA 510(k) clearance for the ORTHO ACTIVE KNEE BRACE.

Submitted by Ortho Active Appliances , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1984 after a review of 9 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 Ortho Active Appliances , Ltd. devices

Submission Details

510(k) Number K842790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date August 08, 1984
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -