Cleared Traditional

K862115 - DEKNA BAND KIT (FDA 510(k) Clearance)

Class I Physical Medicine device.

K862115 · Deknatel, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
77d
Days
Class 1
Risk

K862115 is an FDA 510(k) clearance for the DEKNA BAND KIT. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Deknatel, Inc. (Lake Success, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - the FDA physical medicine device framework. 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 Deknatel, Inc. devices

Submission Details

510(k) Number K862115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date August 19, 1986
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITG Bandage, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.