Cleared Traditional

K832829 - NEO-FLOAT NEONATAL FLOTATION SYS & RHYT

K832829 is the FDA 510(k) clearance for NEO-FLOAT NEONATAL FLOTATION SYS & RHYT by Clinical Data Instruments, Inc.. It is a Class 2 Physical Medicine device (product code IOQ) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K832829 · Clinical Data Instruments, Inc. · Physical Medicine device
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Oct 1983
Decision
46d
Days
Class 2
Risk

K832829 is an FDA 510(k) clearance for the NEO-FLOAT NEONATAL FLOTATION SYS & RHYT. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Clinical Data Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 Clinical Data Instruments, Inc. devices

Submission Details

510(k) Number K832829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date October 04, 1983
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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.