Cleared Traditional

K945042 - ELITE 3 LOW AIR LOSS BED

K945042 is an FDA 510(k) clearance for ELITE 3 LOW AIR LOSS BED, manufactured by Pegabus Egerton, Ltd.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K945042 · Pegabus Egerton, Ltd. · General Hospital
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Mar 1995
Decision
153d
Days
Class 2
Risk

K945042 is an FDA 510(k) clearance for the ELITE 3 LOW AIR LOSS BED. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Pegabus Egerton, Ltd. (Kent Br1 3tu, GB). The FDA issued a Cleared decision on March 16, 1995 after a review of 153 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 Pegabus Egerton, Ltd. devices

FDA 510(k) Submission Details - K945042

510(k) Number K945042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date March 16, 1995
Days to Decision 153 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
24d slower than avg
Panel avg: 129d · This submission: 153d
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 K945042.
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
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2000 MODULAR THIRTY-NINE
K962763 · Equi-Tron Mfg., Inc. · Oct 1996
SSC MODEL 4000 SERIES
K951514 · Ssc Medical Products, Inc. · Mar 1996
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