Cleared Traditional

K933636 - DISPOSE-A-SHEET

K933636 is an FDA 510(k) clearance for DISPOSE-A-SHEET, manufactured by Belmac Healthcare Corp.. The device is a Class 1 General Hospital device with product code KME cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K933636 · Belmac Healthcare Corp. · General Hospital
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Jan 1994
Decision
183d
Days
Class 1
Risk

K933636 is an FDA 510(k) clearance for the DISPOSE-A-SHEET. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Belmac Healthcare Corp. (Tampa, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 183 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 Belmac Healthcare Corp. devices

FDA 510(k) Submission Details - K933636

510(k) Number K933636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date January 26, 1994
Days to Decision 183 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
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 19
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K933636.
OREX MEDICAL BEDDING
K944953 · Thantex Specialties, Inc. · Dec 1994
RECEIVING BLANKET
K904274 · Anago, Inc. · Oct 1990
DEVON DISPOSABLE HEAD POSITIONER COVER
K894170 · Devon Industries, Inc. · Sep 1989
DEPEND UNDERPAD
K870522 · Kimberly-Clark Corp. · Mar 1987
KIMLON DISPOSABLE BLANKET
K863179 · Kimberly-Clark Corp. · Aug 1986
SINGLE-USE PATIENT UNDERPAD
K862348 · Procter & Gamble Mfg. Co. · Jul 1986