Cleared Traditional

K832487 - DRAW SHEET

K832487 is the FDA 510(k) clearance for DRAW SHEET by American Threshold Industries, Inc.. It is a Class 1 General Hospital device (product code KME) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K832487 · American Threshold Industries, Inc. · General Hospital
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Feb 1984
Decision
203d
Days
Class 1
Risk

K832487 is an FDA 510(k) clearance for the DRAW SHEET, ANTI-MICROBIAL. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by American Threshold Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Threshold Industries, Inc. devices

Submission Details

510(k) Number K832487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date February 13, 1984
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K832487.
REFLECTIVE BLANKET
K860066 · O.R. Concepts, Inc. · Feb 1986
ATTENDS DISPOS. UNDERPAD
K853880 · Procter & Gamble Mfg. Co. · Oct 1985
DISPOSABLE PATIENT BLANKET
K843038 · Anago, Inc. · Oct 1984
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981
STERILIZATION PROCESS/BABY BLANKET
K792626 · Procter & Gamble Mfg. Co. · Jan 1980