Cleared Traditional

K964223 - CLINITRON RITE-HITE

K964223 is an FDA 510(k) clearance for CLINITRON RITE-HITE, manufactured by Hill-Rom, Inc.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K964223 · Hill-Rom, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
217d
Days
Class 2
Risk

K964223 is an FDA 510(k) clearance for the CLINITRON RITE-HITE. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on May 28, 1997 after a review of 217 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.

FDA 510(k) Submission Details - K964223

510(k) Number K964223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date May 28, 1997
Days to Decision 217 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 116d · This submission: 217d
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

All 27
Devices cleared under the same product code (INX) and FDA review panel - the closest regulatory comparables to K964223.
HOME CARE BEAD BED
K972176 · Kinetic Concepts, Inc. · Jan 1998
CLINITRON ELEXIS
K943385 · Ssi Medical Services, Inc. · Feb 1995
CLINITRON AT HOME AIR FLUIDED THERAPY
K942184 · Ssi Medical Services, Inc. · Feb 1995
X-20 AIR SUPPORT BED
K931168 · American Life Support Technology, Inc. · Feb 1994
LOW AIR LOSS MATTRESS, MODIFICATION
K934689 · Cardio Systems, Inc. · Feb 1994
DYLNAMEDICS A.S.A.P.
K924973 · Dynamedics, Inc. · Oct 1993
K964223 · CLINITRON RITE-HITE
Download PDF FDA Summary Hill-Rom, Inc.