510(k) · Cleared
ClearedHome Care Bead Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · INX Bed, Air Fluidized
Cleared on Jan 16, 1998 as substantially equivalent to K881917 (Kinetic Concepts, Inc., 1988) after a 221-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 16, 1998
- Review
- 221 days
- Class
- Class II
- Product code
- INX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881917 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK881917 FluidairKinetic Concepts, Inc. · 1988
- This deviceK972176 Home Care Bead BedKinetic Concepts, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881917 | Fluidair | Kinetic Concepts, Inc. | 1988 | — |
| 0 (this device) | K972176 | Home Care Bead Bed | Kinetic Concepts, Inc. | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K881917 | FluidairSummary page 1…of Device: Home Care Bead Bed II. Classification Name: Bed, Air Fluidized Therapy, Powered (per 21 CFR 890.5160) j11 8 Substantial Equivalence: . FluidAirw, 510(k) No. K881917 IVv. Device Description: The Home Care Bead Bed is designed to provide Air Fluidized Therapy by supporting the patient on a sur… | 1988 |
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.
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 Home Care Bead Bed is indicated for patients who would benefit from advanced pressure relief and a dry patient environment. Particular classes of such patients include (among others), victims of the following:
Pressure Ulcers - especially draining wounds
Skin Flaps and Grafts
Bums
Acute Exfoliative Dermatitis
Oncology:
Aids in pain relief
Reduces risk of Pathological Fractures
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/K972176 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972176: Home Care Bead Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972176
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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