510(k) · Cleared
ClearedPulse 2.0, Pulse Pro 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NormaTec Industries, LP · IRP Massager, Powered Inflatable Tube
Cleared on Dec 27, 2018 as substantially equivalent to K160608 (NormaTec Industries, LP, 2016) after a 41-day review. Its family tree reaches back 7 generations to 1985. 10 later devices descend from it.
- Decided
- Dec 27, 2018
- Review
- 41 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K850316 (1985). 18 ancestors in all, the oldest K810338 (1981). 10 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 6 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 5 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 4 generations backK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- 3 generations backK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- 2 generations backK122154 Powerplay Muscle MassagerFig, LLC · 2012
- 1 generation backK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- This deviceK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- Descendant · cites it directly · 7 of its ownK220217 Normatec 3NormaTec Industries, LP · 2022
- Descendant · 2 generations on · 3 of its ownK240122 Normatec EliteNormaTec Industries, LP · 2024
- Descendant · 2 generations on · 2 of its ownK221666 Normatec GoNormaTec Industries, LP · 2022
- Descendant · 3 generations on · 0 of its ownK260529 Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251905 Normatec Elite HipNormaTec Industries, LP · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K220217Normatec 3NormaTec Industries, LP · 2022 · cites it directly7descendants
- K240122Normatec EliteNormaTec Industries, LP · 2024 · 2 generations on3descendants
- K221666Normatec GoNormaTec Industries, LP · 2022 · 2 generations on2descendants
- K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251905Normatec Elite HipNormaTec Industries, LP · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −6 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −5 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −4 | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −3 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| −2 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| −1 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| 0 (this device) | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
| +1 | K220217 | Normatec 3 | NormaTec Industries, LP | 2022 | — |
| +2 | K240122 | Normatec Elite | NormaTec Industries, LP | 2024 | — |
| +2 | K221666 | Normatec Go | NormaTec Industries, LP | 2022 | — |
| +3 | K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | 2026 | — |
| +3 | K251905 | Normatec Elite Hip | NormaTec Industries, LP | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K160608 | NormaTec Pulse and NormaTec Pulse ProSummary page 4…tube massager Name: Product Code: IRP Class II Device Name: Pulse 2.0, Pulse Pro 2.0 Predicate Device: K160608 – NormaTec Pulse and Pulse Pro Device Description The NormaTec Pulse 2.0 and Pulse Pro 2.0 are powered inflatable tube massagers… | 2016 |
What descends from it? (10)
3 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?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K220217 (NormaTec Industries, LP, 2022) has gone furthest, with 7 descendants of its own.
- 7 other devices also cite its predicate K160608.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 NormaTec Pulse 2.0 and Pulse Pro 2.0 are air pressure massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183169: Pulse 2.0, Pulse Pro 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183169
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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