Cleared Traditional

K920112 - CLINITRON C-II

K920112 is an FDA 510(k) clearance for CLINITRON C-II, manufactured by Support Systems Intl.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K920112 · Support Systems Intl. · Physical Medicine device
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Jan 1992
Decision
14d
Days
Class 2
Risk

K920112 is an FDA 510(k) clearance for the CLINITRON C-II. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Support Systems Intl. (Chicago, US). The FDA issued a Cleared decision on January 24, 1992 after a review of 14 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 Support Systems Intl. devices

FDA 510(k) Submission Details - K920112

510(k) Number K920112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1992
Decision Date January 24, 1992
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
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 K920112.
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