Cleared Traditional

K820517 - CONSTRUCTA FOAM (FDA 510(k) Clearance)

K820517 · Alimed, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
13d
Days
-
Risk

K820517 is an FDA 510(k) clearance for the CONSTRUCTA FOAM.

Submitted by Alimed, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1982 after a review of 13 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 Alimed, Inc. devices

Submission Details

510(k) Number K820517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1982
Decision Date March 10, 1982
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -