Cleared Traditional

K972115 - VOLKER HOSPITAL BED, MODEL K960

K972115 is an FDA 510(k) clearance for VOLKER HOSPITAL BED, manufactured by Volker Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972115 · Volker Healthcare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
85d
Days
Class 2
Risk

K972115 is an FDA 510(k) clearance for the VOLKER HOSPITAL BED, MODEL K960. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Volker Healthcare, Inc. (Great Neck,, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 85 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.

View all Volker Healthcare, Inc. devices

FDA 510(k) Submission Details - K972115

510(k) Number K972115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date August 29, 1997
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K972115.
VAIL 1000 ENCLOSED BED
K982783 · Vail Products, Inc. · Oct 1998
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
K974296 · Invacare Corp. · Jan 1998
BENEFIT B3--- SERIES
K974254 · M.C. Healthcare Products, Inc. · Dec 1997
SOMA 900 TRANSPORT BED
K971546 · Nova Technologies, Inc. · Jul 1997
VAIL 2000 ENCLOSED BED
K963622 · Vail Products, Inc. · May 1997
VAIL 3000 BED ENCLOSURE
K963589 · Vail Products, Inc. · Apr 1997