510(k) · Cleared
Recalled · 2012Clinitron Rite-Hite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · INX Bed, Air Fluidized
Cleared on May 28, 1997 as substantially equivalent to K943385 (Ssi Medical Services, Inc., 1995) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 2 times.
- Decided
- May 28, 1997
- Review
- 217 days
- Class
- Class II
- Product code
- INX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942184 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942184 Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 1995 · Recalled
- This deviceK964223 Clinitron Rite-HiteHill-Rom, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942184 | Clinitron at Home Air Fluided Therapy | Ssi Medical Services, Inc. | 1995 | 2 |
| 0 (this device) | K964223 | Clinitron Rite-Hite | Hill-Rom, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in INX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943385 | Clinitron ElexisSummary page 1…Number: Classification: 510(k) Number: CLINITRON® RITEeHITE™ Air Fluidized Therapy INX (21CFR Part 890.5160) Class II Device CLINITRON ELEXIS® C-10 INX, Class II K943385 CLINITRON® ATeHOME™ Air Fluidized Therapy C-6 INX, Class Il K942184 22 5. General Description The CLINITRON… | 1995 |
| * | K942184 | Clinitron at Home Air Fluided TherapySummary page 1…idized Therapy INX (21CFR Part 890.5160) Class II Device CLINITRON ELEXIS® C-10 INX, Class II K943385 CLINITRON® ATeHOME™ Air Fluidized Therapy C-6 INX, Class Il K942184 22 5. General Description The CLINITRON® RITEeHITE™ Air F luldlzed Therapy Unit combines the best features of t… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2012 | Not classified | Z-1131-2012 | Nonconforming Material/Component | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and… |
| Feb 3, 2012 | Not classified | Z-1132-2012 | Nonconforming Material/Component | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All INX devicesINX Bed, Air Fluidized: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INX
FDA has decided no INX device since 2007.
Median 510(k) review, days · INX
Too few INX 510(k)s in any year since 2007 to give a median.
Recalls per year · INX
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INX
170in 2025
MAUDE reports naming product code INX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 0 | — | 2 | 29 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 2 | 12 |
| 2013 | 0 | — | 0 | 352 |
| 2014 | 0 | — | 0 | 282 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 60 |
| 2024 | 0 | — | 0 | 80 |
| 2025 | 0 | — | 0 | 170 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CLINITRON® RITESHITE"™ Air Fluidized Therapy 1s intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain…
Read the full statement (114 words)
The CLINITRON® RITESHITE"™ Air Fluidized Therapy 1s intended for medical
purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in
circulation. This bed will be an ideal support for patients who have advanced pressure
ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation
and any other conditions appropriate for air-fluidized therapy. The bed also can be used
for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome,
purpura fulminans, aid in infection control, induce relaxation which may reduce need for
sedative and pain medication, improve patient outcome, and reduce wound healing time.
The bed will permit easy positioning and egress, thereby enhancing the independence of
residents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964223: Clinitron Rite-Hite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026