Cleared Traditional

K802791 - ZINC PASTE BANDAGE

K802791 · Secol Co. · General & Plastic Surgery device

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Dec 1980

Decision

43d

Days

Risk

K802791 is an FDA 510(k) clearance for the ZINC PASTE BANDAGE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Secol Co. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Secol Co. devices

FDA 510(k) Submission Details - K802791

510(k) Number	K802791 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 04, 1980
Decision Date	December 17, 1980
Days to Decision	43 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

72d faster than avg

Panel avg: 115d · This submission: 43d

Pathway characteristics

Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 267

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K802791.

TEGADERM TRANSPARENT DRESSING

K812678 · 3M Company · Jan 1982

DRESSING CHANGE FOR G TUBE

K803115 · American Medical Disposable, Inc. · Jan 1981

HYPERALIMENTATION DRESSING CHANGE TRAY

K803114 · American Medical Disposable, Inc. · Dec 1980

JELONET PARAFFIN GAUZE DRESSINGS

K791573 · Acme United Corp. · Sep 1979

I.V. START KIT

K780222 · Marion Laboratories, Inc. · Mar 1978

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K802791

Secol Co.

Mchenry, IL · US

Regulatory profile

18 submissions 18 cleared

100% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: December 17, 1980. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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510k Database

510(k) clearances indexed 175,972

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FDA monthly sync September 5, 2026