Cleared Traditional

K925576 - BURKE BARIATRIC TREATMENT SYSTEM II

K925576 is an FDA 510(k) clearance for BURKE BARIATRIC TREATMENT SYSTEM II, manufactured by Burke Mobility Products. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K925576 · Burke Mobility Products · General Hospital
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Jun 1993
Decision
213d
Days
Class 2
Risk

K925576 is an FDA 510(k) clearance for the BURKE BARIATRIC TREATMENT SYSTEM II. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Burke Mobility Products (Mission, US). The FDA issued a Cleared decision on June 4, 1993 after a review of 213 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 Burke Mobility Products devices

FDA 510(k) Submission Details - K925576

510(k) Number K925576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date June 04, 1993
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
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 K925576.
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993
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