Cleared Traditional

K901378 - TENSOPLUS LITE

K901378 is an FDA 510(k) clearance for TENSOPLUS LITE, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K901378 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Jun 1990
Decision
82d
Days
Class 1
Risk

K901378 is an FDA 510(k) clearance for the TENSOPLUS LITE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 82 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.

FDA 510(k) Submission Details - K901378

510(k) Number K901378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date June 12, 1990
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K901378.
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · Fraass Survival Systems, Inc. · Aug 1991
MONTROSE DRESSING APPLICATORS
K905519 · Olemunda Pty , Ltd. · Mar 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991
HYDRASORB(TM)
K897156 · Avitar, Inc. · Feb 1990
SORBEX(TM) SOFT SPONGE
K895654 · Fountain Pharmaceuticals, Inc. · Feb 1990
HERMAL WOUND CARE KIT
K895817 · Stiefel Research Institute, Inc. · Jan 1990
K901378 · TENSOPLUS LITE
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