510(k) · Cleared
ClearedPressure Therapy System PT1003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Senyang Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Feb 19, 2019 as substantially equivalent to K161907 (Xiamen Senyang Co., Ltd., 2017) after a 265-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Feb 19, 2019
- Review
- 265 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914774 (1992). 7 ancestors in all, the oldest K915638 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
- 5 generations backK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
- 4 generations backK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
- 3 generations backK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
- 2 generations backK113275 Compressible Limb Therapy SystemWonjin Mulsan Co., Ltd. · 2012
- 1 generation backK161907 Pressure Therapy SystemXiamen Senyang Co., Ltd. · 2017
- This deviceK181409 Pressure Therapy System PT1003Xiamen Senyang Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914774 | Multipulse Sequential Compression Unit | Talley Group, Ltd. | 1992 | — |
| −5 | K013061 | Biotouch Massage Therapy System | Tactile Systems Technology, Inc. | 2002 | — |
| −4 | K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | 2009 | — |
| −3 | K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) | Wonjin Mulsan Co., Ltd. | 2010 | — |
| −2 | K113275 | Compressible Limb Therapy System | Wonjin Mulsan Co., Ltd. | 2012 | — |
| −1 | K161907 | Pressure Therapy System | Xiamen Senyang Co., Ltd. | 2017 | — |
| 0 (this device) | K181409 | Pressure Therapy System PT1003 | Xiamen Senyang Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 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? (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 |
|---|---|---|---|
| * | K161907 | Pressure Therapy SystemSummary page 4…on Medical Specialty Physical Medicine Regulation Number 890.5650 Product Code IRP Classification Class II C. Predicate device: K161907 Pressure Therapy System PT1002 produced by XIAMEN SENYANG CO., LTD. D. Indications for Use: The device is indicated for use by m… | 2017 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymph edema, edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymph edema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181409: Pressure Therapy System PT1003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181409
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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