Cleared Traditional

K831821 - PNEUMATIC/ELECTRIC/HYDRAULIC BED

K831821 is an FDA 510(k) clearance for PNEUMATIC/ELECTRIC/HYDRAULIC BED, manufactured by G.W. Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K831821 · G.W. Healthcare, Inc. · General Hospital
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Aug 1983
Decision
63d
Days
Class 2
Risk

K831821 is an FDA 510(k) clearance for the PNEUMATIC/ELECTRIC/HYDRAULIC BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by G.W. Healthcare, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K831821

510(k) Number K831821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1983
Decision Date August 08, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
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 67
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K831821.
STRYKER 988 ICU BED
K852674 · Stryker Corp. · Jul 1985
MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES
K851551 · Daun International, Inc. · May 1985
KINAIR, LOW AIR LOSS BED
K843781 · Kinetic Concepts, Inc. · Jan 1985
HEALTHCARE MODEL #175/176 BED SERIES
K830559 · G.W. Healthcare, Inc. · Mar 1983
NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS
K821185 · Dase Co. · Sep 1982
LIC TURNOVER BED
K811897 · Century Manufacturing Co. · Jul 1981
K831821 · PNEUMATIC/ELECTRIC/HYDRAULIC BED
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