Cleared Traditional

BED SHEET, PILLOW CASE (K884380) - FDA 510(k) Clearance

Class I General Hospital device.

K884380 · Saybrex Intl., Inc. · General Hospital
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Nov 1988
Decision
21d
Days
Class 1
Risk

K884380 is an FDA 510(k) clearance for the BED SHEET, PILLOW CASE. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Saybrex Intl., Inc. (Beverly Hills, US). The FDA issued a Cleared decision on November 8, 1988 after a review of 21 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 Saybrex Intl., Inc. devices

Submission Details

510(k) Number K884380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date November 08, 1988
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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

Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K884380.
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
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