Cleared Traditional

K802021 - PEDIBAND CAT.#195-197

K802021 is an FDA 510(k) clearance for PEDIBAND CAT.#195-197, manufactured by Pollak (Intl.), Ltd.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K802021 · Pollak (Intl.), Ltd. · General & Plastic Surgery device
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Sep 1980
Decision
27d
Days
Class 1
Risk

K802021 is an FDA 510(k) clearance for the PEDIBAND CAT.#195-197. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 27 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 Pollak (Intl.), Ltd. devices

FDA 510(k) Submission Details - K802021

510(k) Number K802021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 16, 1980
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 52
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K802021.
ENSURE DRESSING
K830593 · Warner-Lambert Co. · Apr 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · Chesebrough-Pond'S U.S.A. Co. · Mar 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982
FIXOMULL STERILE
K800953 · Beiersdorf, Inc. · May 1980
AIRSTRIP THEATRE WARD DRESSING
K791369 · Acme United Corp. · Aug 1979