510(k) · Cleared
ClearedAir Compression Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Lifotronic Technology Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Jun 22, 2020 as substantially equivalent to K102320 (Daesung Maref Co., Ltd., 2011) after a 287-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jun 22, 2020
- Review
- 287 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914774 (1992). 9 ancestors in all, the oldest K810338 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
- 4 generations backK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
- 3 generations backK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
- 2 generations backK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
- 1 generation backK102320 Compressible Limb and Circulation Therapy System Model LX7(V7)Daesung Maref Co., Ltd. · 2011
- This deviceK192466 Air Compression Therapy SystemShenzhen Lifotronic Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914774 | Multipulse Sequential Compression Unit | Talley Group, Ltd. | 1992 | — |
| −4 | K013061 | Biotouch Massage Therapy System | Tactile Systems Technology, Inc. | 2002 | — |
| −3 | K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | 2009 | — |
| −2 | K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) | Wonjin Mulsan Co., Ltd. | 2010 | — |
| −1 | K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7) | Daesung Maref Co., Ltd. | 2011 | — |
| 0 (this device) | K192466 | Air Compression Therapy System | Shenzhen Lifotronic Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K102320 | Compressible Limb and Circulation Therapy System Model LX7(V7)Summary page 4…code: IRP Regulation Class: II Regulation Number: 21 CFR 890.5650 3. Predicate Device Information 510(k) submitter/holder: DAESING MAREF CO LTD 510(K) Number: K102320 Device: Compressible Limb Therapy System Trade name: LX7(V7) Classification Name: massager, powered… | 2011 |
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 28 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K102320.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192466: Air Compression Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192466
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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