Cleared Traditional

K884791 - PERME-AID TRANSPARENT DRESSING, #11XX

K884791 is an FDA 510(k) clearance for PERME-AID TRANSPARENT DRESSING, manufactured by Nitto Denko Technical Corp.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K884791 · Nitto Denko Technical Corp. · General & Plastic Surgery device
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May 1989
Decision
170d
Days
Class 1
Risk

K884791 is an FDA 510(k) clearance for the PERME-AID TRANSPARENT DRESSING, #11XX. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Nitto Denko Technical Corp. (Santa Clara, US). The FDA issued a Cleared decision on May 4, 1989 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nitto Denko Technical Corp. devices

FDA 510(k) Submission Details - K884791

510(k) Number K884791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1988
Decision Date May 04, 1989
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
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 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K884791.
2018 ARTERIAL/VENOUS PRESSURE DRESSING
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K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
POLYMER ADHESIVE BANDAGE
K883391 · Marion Laboratories, Inc. · Mar 1989