510(k) · Cleared
ClearedSilkair Low Airloss Therapy
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 Jul 3, 1997 as substantially equivalent to K863047 (Ssi Medical Services, Inc., 1986) after a 210-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 3, 1997
- Review
- 210 days
- Class
- Class II
- Product code
- IOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863047 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK863047 FlexicairSsi Medical Services, Inc. · 1986 · Recalled
- This deviceK964873 Silkair Low Airloss TherapyHill-Rom, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863047 | Flexicair | Ssi Medical Services, Inc. | 1986 | 5 |
| 0 (this device) | K964873 | Silkair Low Airloss Therapy | 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? (1)
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 |
|---|---|---|---|
| * | K863047 | FlexicairSummary page 1…510(k) Number: SILKAIR™ Low Airloss Therapy I0Q (21CFR Part 890.5170) Class II Device Flexicair® Low Airloss Therapy Unit I0Q (21CFR Part 890.5170) Class II Device K863047 l1of3 5. General Description This product provides the therapeutic surface features and the head and leg elevat… | 1986 |
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 a recall.
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?
Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.
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/K964873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964873: Silkair Low Airloss Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964873
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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