510(k) · Cleared
ClearedClinidyne Rotational Therapy Mattress System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gaymar Industries, Inc. · IKZ Bed, Patient Rotation, Powered
Cleared on Apr 30, 1997 after a 287-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 30, 1997
- Review
- 287 days
- Class
- Class II
- Product code
- IKZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 IKZ? 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 |
|---|---|---|---|
| * | — | CLA 1400 System Named without a submission number | |
| * | — | CLD-1000 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IKZ devicesIKZ Bed, Patient Rotation, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKZ
FDA has decided no IKZ device since 2007.
Median 510(k) review, days · IKZ
Too few IKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · IKZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKZ
12in 2025
MAUDE reports naming product code IKZ, 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 | 7 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 1 | 26 |
| 2011 | 0 | — | 1 | 48 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 1 | 294 |
| 2014 | 0 | — | 0 | 80 |
| 2015 | 0 | — | 0 | 40 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 35 |
| 2018 | 0 | — | 1 | 28 |
| 2019 | 0 | — | 0 | 27 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 1 | 11 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.
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/K962788 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962788: Clinidyne Rotational Therapy Mattress System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026