Cleared Traditional

K963589 - VAIL 3000 BED ENCLOSURE

K963589 is an FDA 510(k) clearance for VAIL 3000 BED ENCLOSURE, manufactured by Vail Products, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K963589 · Vail Products, Inc. · General Hospital
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Apr 1997
Decision
224d
Days
Class 2
Risk

K963589 is an FDA 510(k) clearance for the VAIL 3000 BED ENCLOSURE. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Vail Products, Inc. (Toledo, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 224 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 Vail Products, Inc. devices

FDA 510(k) Submission Details - K963589

510(k) Number K963589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1996
Decision Date April 21, 1997
Days to Decision 224 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 129d · This submission: 224d
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 27
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K963589.
VOLKER HOSPITAL BED, MODEL K960
K972115 · Volker Healthcare, Inc. · Aug 1997
SOMA 900 TRANSPORT BED
K971546 · Nova Technologies, Inc. · Jul 1997
VAIL 2000 ENCLOSED BED
K963622 · Vail Products, Inc. · May 1997
TOTALCARE
K962942 · Hill-Rom, Inc. · Feb 1997
SOMA SAFE ENCLOSURE
K963701 · Nova Technology Corp. · Jan 1997
NOVABED PATIENT TRANSFER SYSTEM
K964246 · Nova Technology Corp. · Jan 1997