Cleared Traditional

K810240 - CLINIGUARD STERILE

K810240 is the FDA 510(k) clearance for CLINIGUARD STERILE by Clinipad Corp.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K810240 · Clinipad Corp. · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Feb 1981

Decision

22d

Days

Class 1

Risk

K810240 is an FDA 510(k) clearance for the CLINIGUARD STERILE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Clinipad Corp. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Clinipad Corp. devices

Submission Details

510(k) Number	K810240 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 1981
Decision Date	February 19, 1981
Days to Decision	22 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

93d faster than avg

Panel avg: 115d · This submission: 22d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KMF Bandage, Liquid
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 880.5090

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 - KMF Bandage, Liquid

All 38

Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K810240.

COMFEEL CONTOUR DRESSING

K920925 · Coloplast A/S · May 1992

DUODERM* CONTROL GEL FORMULA BORDER DRESSING

K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990

VIGILON PRIMARY WOUND DRESSING, STERILE

K820134 · C.R. Bard, Inc. · Feb 1982

DRESSING, ENVIRON WOUND

K782008 · Abbott Laboratories · May 1979

KIMLON BEDGARD UNDERPAD

K790384 · Kimberly-Clark Corp. · Apr 1979

HYDRON BURN BANDAGE MANUAL APPLICATION

K781406 · Abbott Laboratories · Sep 1978

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K810240

Clinipad Corp.

Mchenry, IL · US

Regulatory profile

16 submissions 12 cleared

75% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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 . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active