510(k) · Cleared
ClearedRumors Dynamic Air Therapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · IKZ Bed, Patient Rotation, Powered
Cleared on Feb 2, 1998 after a 242-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 2, 1998
- Review
- 242 days
- Class
- Class II
- Product code
- IKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972111 Rumors Dynamic Air Therapy UnitHill-Rom, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972111 | Rumors Dynamic Air Therapy Unit | Hill-Rom, Inc. | 1998 | — |
| +1 | K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System… | Hill-Rom | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | EFICA CC® Dynamic Air Therapy® Unit manufactured by Hill-Rome Named without a submission number | |
| * | — | PULMONEX™ Dynamic Air Therapy® Unit manufactured by Hill-Rome Named without a submission number | |
| * | — | SYNERGY F.A.S.T. manufactured by Cardio Systems Named without a submission number | |
| * | — | TriaDyne™ Critical Care Healing System manufactured by KCI Therapeutic Services Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2 | 2013 | 0 |
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.
What does this lineage say?
- Of its descendants, K122473 (Hill-Rom, 2013) has gone furthest, with 0 descendants of its own.
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 RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.
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/K972111 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972111: Rumors Dynamic Air Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972111
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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