Cleared Traditional

K962250 - CARROLL HEALTHCARE DLX 2300-111 ELECTRI...

K962250 is an FDA 510(k) clearance for CARROLL HEALTHCARE DLX 2300-111 ELECTRI..., manufactured by Carroll Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K962250 · Carroll Healthcare, Inc. · General Hospital
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Oct 1996
Decision
131d
Days
Class 2
Risk

K962250 is an FDA 510(k) clearance for the CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Carroll Healthcare, Inc. (Ontario, CA). The FDA issued a Cleared decision on October 21, 1996 after a review of 131 days - within the typical 510(k) review window.

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 Carroll Healthcare, Inc. devices

FDA 510(k) Submission Details - K962250

510(k) Number K962250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1996
Decision Date October 21, 1996
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K962250.
IBED WIRELESS WITH IBED AWARENESS
K103536 · Stryker Corporation · Dec 2010
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
K974296 · Invacare Corp. · Jan 1998
TOTALCARE
K962942 · Hill-Rom, Inc. · Feb 1997
BARIKARE PLUS
K945664 · Kinetic Concepts, Inc. · Feb 1995
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993