Cleared Traditional

K901096 - LUMISCOPE ALTERNATING PRESSURE PAD & PUMP

K901096 is an FDA 510(k) clearance for LUMISCOPE ALTERNATING PRESSURE PAD & PUMP, manufactured by Lumiscope Co., Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K901096 · Lumiscope Co., Inc. · General Hospital
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Aug 1990
Decision
167d
Days
Class 2
Risk

K901096 is an FDA 510(k) clearance for the LUMISCOPE ALTERNATING PRESSURE PAD & PUMP. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 167 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 Lumiscope Co., Inc. devices

FDA 510(k) Submission Details - K901096

510(k) Number K901096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date August 21, 1990
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 129d · This submission: 167d
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 K901096.
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HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
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CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
K882092 · Gaymar Industries, Inc. · Jul 1988