Cleared Traditional

K770486 - SHEET KIT

K770486 is the FDA 510(k) clearance for SHEET KIT by American Hospital Supply Corp.. It is a Class 1 General Hospital device (product code KME) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K770486 · American Hospital Supply Corp. · General Hospital
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Apr 1977
Decision
46d
Days
Class 1
Risk

K770486 is an FDA 510(k) clearance for the SHEET KIT, STRETCHER, DISPOSABLE. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1977 after a review of 46 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 American Hospital Supply Corp. devices

Submission Details

510(k) Number K770486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1977
Decision Date April 29, 1977
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 12
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K770486.
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978
TOWELS, SHEETS, PILLOWCASES
K781227 · Abco Dealers, Inc. · Oct 1978
PILLOWS- SINGLE PATIENT USE
K781354 · Abco Dealers, Inc. · Oct 1978
PLASTIC DISPOSABLE BIB
K761108 · Fred Sammons, Inc. · Dec 1976
TERRYCLOTH BIBS
K761109 · Fred Sammons, Inc. · Dec 1976