Cleared Traditional

K911893 - EASY ACCESS BED

K911893 is an FDA 510(k) clearance for EASY ACCESS BED, manufactured by Willis Therapeutic Innovations, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K911893 · Willis Therapeutic Innovations, Inc. · General Hospital
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Nov 1991
Decision
207d
Days
Class 2
Risk

K911893 is an FDA 510(k) clearance for the EASY ACCESS BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Willis Therapeutic Innovations, Inc. (Westhampton Beach, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 207 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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 Willis Therapeutic Innovations, Inc. devices

FDA 510(k) Submission Details - K911893

510(k) Number K911893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date November 22, 1991
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FNL Bed, Ac-powered Adjustable Hospital

All 28
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K911893.
STRYKER MPS ACUTE CARE BED
K931482 · Stryker Corp. · Sep 1993
THE ADVANCE SERIES FROM HILL-ROM
K922352 · Hill-Rom, Inc. · Oct 1992
CRITICAL CARE HOSPITAL BED (ICU/CCU)
K915437 · Hill-Rom, Inc. · Jun 1992
INVACARE EXTENDED CARE NURSING HOME BED
K900151 · Invacare Corp. · Jun 1990
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · Stryker Corp. · Feb 1988
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
K864172 · Hill-Rom, Inc. · Nov 1986