Cleared Traditional

K950191 - THE LOTECON PERSONAL CARE SYSTEM

K950191 is an FDA 510(k) clearance for THE LOTECON PERSONAL CARE SYSTEM, manufactured by Lotecon, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K950191 · Lotecon, Inc. · General Hospital
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Jun 1995
Decision
146d
Days
Class 2
Risk

K950191 is an FDA 510(k) clearance for the THE LOTECON PERSONAL CARE SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Lotecon, Inc. (Greenville, US). The FDA issued a Cleared decision on June 12, 1995 after a review of 146 days - within the typical 510(k) review window.

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 Lotecon, Inc. devices

FDA 510(k) Submission Details - K950191

510(k) Number K950191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date June 12, 1995
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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 K950191.
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · Span-America Medical Systems, Inc. · Jan 1996
PRESSUREGUARD IV
K953503 · Span-America Medical Systems, Inc. · Oct 1995
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