510(k) · Cleared
Recalled · 2003KT Air Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · FNM Mattress, Air Flotation, Alternating Pressure
Cleared on Sep 5, 1997 as substantially equivalent to K875321 (Kinetic Concepts, Inc., 1988) and 2 other predicates after a 210-day review. Its family tree reaches back 1 generation to 1988. It has been recalled once.
- Decided
- Sep 5, 1997
- Review
- 210 days
- Class
- Class II
- Product code
- FNM
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K875321 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK875321 Modified Rotation Air Fluidized Bed/the TherapulseKinetic Concepts, Inc. · 1988
- This deviceK970468 KT Air BedKinetic Concepts, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875321 | Modified Rotation Air Fluidized Bed/the Therapulse | Kinetic Concepts, Inc. | 1988 | — |
| 0 (this device) | K970468 | KT Air Bed | Kinetic Concepts, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 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 FNM? 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? (3)
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 |
|---|---|---|---|
| * | K875321 | Modified Rotation Air Fluidized Bed/the TherapulseSummary page 1…inAir IV/Therapulse II (KT Air Bed) 1I. Classification Name: Bed, Flotation Therapy, Powered (per 21 CFR 890.5170) 111, Substantial Equivalence: Therapulse, 510(k) No. K875321 KinAir, 510(k) No. 880340 TriaDyne Plus, 510(k) No. 944094 Iv. Device Description: The KinAir 1V, Therapulse 1l (a.k.a. KT Air… | 1988 |
| * | K880340 | Modified Air Fluidized Bed, KinairSummary page 1…ature. The mattress replacement system itself is essentially of the same general construction as the predicate Therapulse (510(k) No. K875321) and the KinAir (510(k) No. K880340 and the substantially equivalent TriaDyne device (510(k) No. K944094). It consists of the fabric support and the various cushions… | 1988 |
| * | K944094 | TriadyneSummary page 1…ame general construction as the predicate Therapulse (510(k) No. K875321) and the KinAir (510(k) No. K880340 and the substantially equivalent TriaDyne device (510(k) No. K944094). It consists of the fabric support and the various cushions. The fabric support is a Gore-Tex fabric assembly for supporting and… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2003 | Not classified | Z-0583-05 | Other | Weld failure causes side rail welds to turn upside down or break off of the bed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All FNM devicesFNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNM
FDA has decided no FNM device since 2007.
Median 510(k) review, days · FNM
Too few FNM 510(k)s in any year since 2007 to give a median.
Recalls per year · FNM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FNM
128in 2025
MAUDE reports naming product code FNM, 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 | 33 |
| 2008 | 0 | — | 4 | 35 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 1 | 56 |
| 2011 | 0 | — | 0 | 291 |
| 2012 | 0 | — | 0 | 303 |
| 2013 | 0 | — | 0 | 223 |
| 2014 | 0 | — | 0 | 80 |
| 2015 | 0 | — | 0 | 80 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 0 | — | 0 | 115 |
| 2019 | 0 | — | 0 | 101 |
| 2020 | 0 | — | 0 | 58 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 197 |
| 2024 | 0 | — | 0 | 254 |
| 2025 | 0 | — | 1 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KinAir IV, Therapulse II Air Bed bed is indicated to assist in the prevention and treatment of the complications of immobility, especially for patients who would benefit from a pressure relieving surface with the additional optional benefit of pneumatic pulsation.
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/K970468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970468: KT Air Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970468
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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