Cleared Traditional

K873368 - TECNOL COMPRESSION KNEE DRESSING (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873368 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Dec 1987
Decision
112d
Days
Class 2
Risk

K873368 is an FDA 510(k) clearance for the TECNOL COMPRESSION KNEE DRESSING. Classified as Legging, Compression, Non-inflatable (product code LLK), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K873368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date December 11, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLK Legging, Compression, Non-inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.