Cleared Traditional

K821835 - BARRIER BURN SHEET

K821835 is an FDA 510(k) clearance for BARRIER BURN SHEET, manufactured by Uhi Corp.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K821835 · Uhi Corp. · General Hospital
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Jul 1982
Decision
10d
Days
Class 1
Risk

K821835 is an FDA 510(k) clearance for the BARRIER BURN SHEET. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Uhi Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - the FDA general hospital 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 Uhi Corp. devices

FDA 510(k) Submission Details - K821835

510(k) Number K821835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1982
Decision Date July 02, 1982
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

KME Device Classification - Class 1, General Controls

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

All 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K821835.
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
PILLOW COVER, ANTI-MICROBIAL
K832486 · American Threshold Industries, Inc. · Feb 1984
DRAW SHEET, ANTI-MICROBIAL
K832487 · American Threshold Industries, Inc. · Feb 1984
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
PATIENT UNDERPAD
K813263 · The Buckeye Cellulose Corp. · Nov 1981
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981