Cleared Traditional

K884440 - TECNOL VARIABLE TENSION BANDAGE

K884440 is an FDA 510(k) clearance for TECNOL VARIABLE TENSION BANDAGE, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K884440 · Tecnol New Jersey Wound Care, Inc. · General & Plastic Surgery device
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Jan 1989
Decision
88d
Days
Class 1
Risk

K884440 is an FDA 510(k) clearance for the TECNOL VARIABLE TENSION BANDAGE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery 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

FDA 510(k) Submission Details - K884440

510(k) Number K884440 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 21, 1988
Decision Date January 17, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 39
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K884440.
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
POLYMER ADHESIVE BANDAGE
K883391 · Marion Laboratories, Inc. · Mar 1989
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · Smith & Nephew United, Inc. · Mar 1989
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
DUODERM(R) CGF
K881050 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
ENVICLUSIVE (TM)
K874554 · Marion Laboratories, Inc. · Mar 1988