Cleared Traditional

K900871 - ALTERNATING PRESSURE PUMP AND PAD SYSTEM

K900871 is an FDA 510(k) clearance for ALTERNATING PRESSURE PUMP AND PAD SYSTEM, manufactured by Three Bears Intl.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K900871 · Three Bears Intl. · General Hospital
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Apr 1990
Decision
39d
Days
Class 2
Risk

K900871 is an FDA 510(k) clearance for the ALTERNATING PRESSURE PUMP AND PAD SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Three Bears Intl. (New Bedford, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Three Bears Intl. devices

FDA 510(k) Submission Details - K900871

510(k) Number K900871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1990
Decision Date April 04, 1990
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 K900871.
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HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
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K882092 · Gaymar Industries, Inc. · Jul 1988