Cleared Traditional

K974254 - BENEFIT B3--- SERIES

K974254 is an FDA 510(k) clearance for BENEFIT B3--- SERIES, manufactured by M.C. Healthcare Products, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K974254 · M.C. Healthcare Products, Inc. · General Hospital
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Dec 1997
Decision
33d
Days
Class 2
Risk

K974254 is an FDA 510(k) clearance for the BENEFIT B3--- SERIES. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by M.C. Healthcare Products, Inc. (Beamsville, Ontario, CA). The FDA issued a Cleared decision on December 16, 1997 after a review of 33 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 M.C. Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K974254

510(k) Number K974254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1997
Decision Date December 16, 1997
Days to Decision 33 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
96d faster than avg
Panel avg: 129d · This submission: 33d
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 16
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