510(k) · Cleared
ClearedVerseo Air Pressure Massager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The American Export Group & International Services · IRP Massager, Powered Inflatable Tube
Cleared on Mar 9, 2010 as substantially equivalent to K040905 (Tohkai Precision Ind., Ltd., 2005) and 2 other predicates after a 214-day review. Its family tree reaches back 4 generations to 1985. 54 later devices descend from it.
- Decided
- Mar 9, 2010
- Review
- 214 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K850316 (1985). 6 ancestors in all. 54 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 3 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 2 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 1 generation backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- This deviceK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- Descendant · cites it directly · 53 of its ownK122154 Powerplay Muscle MassagerFig, LLC · 2012
- Descendant · 2 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- Descendant · 3 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- Descendant · 3 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- Descendant · 3 generations on · 10 of its ownK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K122154Powerplay Muscle MassagerFig, LLC · 2012 · cites it directly53descendants
- K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 2 generations on51descendants
- K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 3 generations on38descendants
- K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 3 generations on20descendants
- K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −3 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −2 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −1 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| 0 (this device) | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| +1 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| +2 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| +3 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| +3 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| +3 | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K040905 | Wellness/JoliveteSummary page 2…Device(s): This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: 1. K040905 - Wellness/Jolivette (Tohkai Precision Ind. Ltd.) 2. K030437 - Relaxor Perfect... (Salton, Inc.) 3. K0715… | 2005 |
| * | K030437 | Relaxor Perfect Touch Air Massaging SystemSummary page 2…ng predicate devices, which are currently in safe and effective commerce: 1. K040905 - Wellness/Jolivette (Tohkai Precision Ind. Ltd.) 2. K030437 - Relaxor Perfect... (Salton, Inc.) 3. K071596 - Portable Air Mass... (Nihon Seimitsu Sokki Co. Ltd.) 6. Performance… | 2003 |
| * | K071596 | Potable Air Massager Putifino, Model AM-7Summary page 2…d effective commerce: 1. K040905 - Wellness/Jolivette (Tohkai Precision Ind. Ltd.) 2. K030437 - Relaxor Perfect... (Salton, Inc.) 3. K071596 - Portable Air Mass... (Nihon Seimitsu Sokki Co. Ltd.) 6. Performance Standards: These devices have been tested under an… | 2008 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122154 | Powerplay Muscle Massager | 2012 | 53 |
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 25 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122154 (Fig, LLC, 2012) has gone furthest, with 53 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. 2010, 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 Versec Air Pressure Massager is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to the treated areas. The Verseo Air Pressure Massager simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092435: Verseo Air Pressure Massager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092435
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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