510(k) · Cleared
ClearedAir Pressure Therapy System (VU-IPC04B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Weiyou Intelligent Technology Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Nov 18, 2024 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Nov 18, 2024
- Review
- 26 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK243320 Air Pressure Therapy System (VU-IPC04B)Xiamen Weiyou Intelligent Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK253064 Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System…Xiamen Weiyou Intelligent Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242615 Intermittent pressure compression system (Compression Pump PT1005A…Xiamen Taotao Technology Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See all- K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…Xiamen Weiyou Intelligent Technology Co., Ltd. · 2026 · cites it directly0descendants
- K242615Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression…Xiamen Taotao Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2024 | — |
| +1 | K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System… | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026 | — |
| +1 | K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg… | Xiamen Taotao Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 IRP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K253064 (Xiamen Weiyou Intelligent Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The Air Pressure Therapy System is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K243320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243320: Air Pressure Therapy System (VU-IPC04B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243320
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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