510(k) · Cleared
ClearedAIRTEC2 Low Air Loss Therapy Bed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Metal, Inc. · IOQ Bed, Flotation Therapy, Powered
Cleared on Nov 17, 1997 after a 290-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 17, 1997
- Review
- 290 days
- Class
- Class II
- Product code
- IOQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. | For pain (] management and pressure relief consider the AerecZ for patlents with arthrms, A]])S or cancer. T
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970364 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970364: AIRTEC2 Low Air Loss Therapy Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970364
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026