Cleared Traditional

K882640 - TECNOL SECURE-ALL PELVIC TRACTION BELT (FDA 510(k) Clearance)

Class I Orthopedic device.

K882640 · Tecnol New Jersey Wound Care, Inc. · Orthopedic device
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Jul 1988
Decision
30d
Days
Class 1
Risk

K882640 is an FDA 510(k) clearance for the TECNOL SECURE-ALL PELVIC TRACTION BELT. Classified as Component, Traction, Non-invasive (product code KQZ), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 27, 1988 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5890 - the FDA orthopedic device regulatory 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 Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K882640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date July 27, 1988
Days to Decision 30 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQZ Component, Traction, Non-invasive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5890
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.