510(k) · Cleared
ClearedFlexicair Exlipse Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom, Inc. · IOQ Bed, Flotation Therapy, Powered
Cleared on May 16, 1997 as substantially equivalent to K951001 (Hill-Rom, Inc., 1995) after a 109-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 16, 1997
- Review
- 109 days
- Class
- Class II
- Product code
- IOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951001 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951001 Flexicair ExlipseHill-Rom, Inc. · 1995
- This deviceK970295 Flexicair Exlipse PlusHill-Rom, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951001 | Flexicair Exlipse | Hill-Rom, Inc. | 1995 | — |
| 0 (this device) | K970295 | Flexicair Exlipse Plus | Hill-Rom, Inc. | 1997 | — |
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 IOQ? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951001 | Flexicair ExlipseSummary page 1…Usual or Classification Name: Portable Powered Flotation Therapy Mattress Proprietary Name: FLEXICAIR® ECLIPSE™ Plus and Ultra 3. PREDICATE DEVICES FLEXICAIR® ECLIPSE™ K951001) manufactured by Hill-Rom FIRST STEP (K930673) manufactured by KCI Therapeutic Services. 4. SUBJECT DEVICE A. Air Supply Unit… | 1995 |
| Kept off the family tree | K930673 | FDA’s K930673 is Premium Our OCR of the scanned summary read K930673, FDA’s number for Premium (Kinetic Concepts, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “FIRST STEP”. Kept off the family tree. Summary page 1…Flotation Therapy Mattress Proprietary Name: FLEXICAIR® ECLIPSE™ Plus and Ultra 3. PREDICATE DEVICES FLEXICAIR® ECLIPSE™ K951001) manufactured by Hill-Rom FIRST STEP (K930673) manufactured by KCI Therapeutic Services. 4. SUBJECT DEVICE A. Air Supply Unit The blower, controller and valves are located… | 1993 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K951001.
How does its category compare?
All IOQ devicesIOQ Bed, Flotation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOQ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · IOQ
Too few IOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · IOQ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOQ
142in 2025
MAUDE reports naming product code IOQ, 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 | — | 1 | 10 |
| 2009 | 0 | — | 4 | 35 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 1 | 9 |
| 2013 | 1 | — | 1 | 15 |
| 2014 | 0 | — | 0 | 35 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 42 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 2 | 22 |
| 2023 | 0 | — | 1 | 111 |
| 2024 | 0 | — | 0 | 392 |
| 2025 | 0 | — | 0 | 142 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The standard FLEXICAIR® ECLIPSE™, the FLEXICAIR® ECLIPSE™ PLUS and the FLEXICAIR® ECLIPSE™ ULTRA Mattress Replacements are intended to provide low-airloss therapy for different ranges of patient weights. The standard FLEXICAIR® ECLIPSE™ used on general Med-Surg or specialty beds covers all patient weights up to 300 Ibs. The FLEXICAIR® ECLIPSE™ PLUS covers patient weights from 301 Ibs to 450 Ibs on Hill-Rom Century, Centra and Advance 1000 bed frames and on the Stryker MPS bed frame. The FLEXICAIR® ECLIPSE™ ULTRA covers patient weights from 451 to 800 Ibs on the Hill-Rom Magnum/Magnum II bed frames.
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/K970295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970295: Flexicair Exlipse Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970295
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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