Cleared Traditional

K881705 - MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM

K881705 is an FDA 510(k) clearance for MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM, manufactured by Surgi-Med, Inc.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K881705 · Surgi-Med, Inc. · Physical Medicine device
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Jul 1988
Decision
85d
Days
Class 2
Risk

K881705 is an FDA 510(k) clearance for the MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Surgi-Med, Inc. (Lansing, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5160 - the FDA physical medicine 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 Surgi-Med, Inc. devices

FDA 510(k) Submission Details - K881705

510(k) Number K881705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1988
Decision Date July 13, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INX Device Classification - Class 2, Special Controls

Product Code INX Bed, Air Fluidized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5160
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - INX Bed, Air Fluidized

Devices cleared under the same product code (INX) and FDA review panel - the closest regulatory comparables to K881705.
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