Cleared Traditional

K945041 - PARAGON PORTABLE

K945041 is an FDA 510(k) clearance for PARAGON PORTABLE, manufactured by Pegabus Egerton, Ltd.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K945041 · Pegabus Egerton, Ltd. · General Hospital
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Mar 1995
Decision
153d
Days
Class 2
Risk

K945041 is an FDA 510(k) clearance for the PARAGON PORTABLE. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), 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 880.5550 - 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 - K945041

510(k) Number K945041 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.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 - FNM Mattress, Air Flotation, Alternating Pressure

All 52
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K945041.
BAZOOKA SYSTEM
K951469 · Innovative Medical Systems, Inc. · Jun 1995
PRESSUREGUARD IV
K951112 · Span-America Medical Systems, Inc. · Jun 1995
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995
TURBO II
K933402 · Kinetic Concepts, Inc. · Mar 1994
PRESSUREGUARD IV
K932681 · Span-America Medical Systems, Inc. · Nov 1993
PREMIUM
K930673 · Kinetic Concepts, Inc. · Aug 1993