Cleared Traditional

K942184 - CLINITRON AT HOME AIR FLUIDED THERAPY (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942184 · Ssi Medical Services, Inc. · Physical Medicine device
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Feb 1995
Decision
279d
Days
Class 2
Risk

K942184 is an FDA 510(k) clearance for the CLINITRON AT HOME AIR FLUIDED THERAPY. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Ssi Medical Services, Inc. (Charleston, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 279 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Ssi Medical Services, Inc. devices

Submission Details

510(k) Number K942184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date February 07, 1995
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.