Cleared Traditional

K882128 - TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 (FDA 510(k) Clearance)

Class I General Hospital device.

K882128 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Jun 1988
Decision
26d
Days
Class 1
Risk

K882128 is an FDA 510(k) clearance for the TECNOL TIGER PAWS PRODUCT NUMBER 47705-010. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: 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 K882128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1988
Decision Date June 15, 1988
Days to Decision 26 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
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FXP Cover, Shoe, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.