Cleared Traditional

K863748 - HOSPITAL BED

K863748 is an FDA 510(k) clearance for HOSPITAL BED, manufactured by Global Medical Prods, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863748 · Global Medical Prods, Inc. · General Hospital
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Oct 1986
Decision
15d
Days
Class 1
Risk

K863748 is an FDA 510(k) clearance for the HOSPITAL BED. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Global Medical Prods, Inc. (Chicago, US). The FDA issued a Cleared decision on October 9, 1986 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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 - K863748

510(k) Number K863748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1986
Decision Date October 09, 1986
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

FNJ Device Classification - Class 1, General Controls

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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 - FNJ Bed, Manual

All 28
Devices cleared under the same product code (FNJ) and FDA review panel - the closest regulatory comparables to K863748.
CART, ORTHOPEDIC BED, STRYKER
K863685 · Brenner Metal Prod Corp. · Jan 1987
ICU/CPU TRANSPORT TRAY
K864878 · Orthopedic Systems, Inc. · Jan 1987
NESBIT EVANS NURSING HOME BED
K864203 · J. Nesbit Evans & Co. · Nov 1986
COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED
K861678 · Sierra Corp. · May 1986
TIPS AND PADS, CANE,CRUTCH AND WALKER
K854940 · Healthtech Industries, Inc. · Jan 1986
EGERTON TURNING & TILTING NET SUSPEN BED
K832845 · Kinetic Concepts, Inc. · Nov 1983
K863748 · HOSPITAL BED
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