510(k) · Cleared
ClearedProact 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proact Co. · IRP Massager, Powered Inflatable Tube
Cleared on Jun 13, 2001 after a 176-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jun 13, 2001
- Review
- 176 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK003909 Proact 1Proact Co. · 2001
- Descendant · cites it directly · 12 of its ownK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK143185 entré Model PD08-UTactile Systems Technology, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK172770 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK193069 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK172779 AIROS 8 Sequential Compression DeviceAiros Medical, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013 · cites it directly12descendants
- K143185entré Model PD08-UTactile Systems Technology, Inc. · 2015 · 2 generations on4descendants
- K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018 · 2 generations on3descendants
- K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019 · 3 generations on2descendants
- K172779AIROS 8 Sequential Compression DeviceAiros Medical, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003909 | Proact 1 | Proact Co. | 2001 | — |
| +1 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| +2 | K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015 | — |
| +2 | K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
| +3 | K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019 | — |
| +2 | K172779 | AIROS 8 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 142 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, K123647 (Devon Medical, Inc., 2013) has gone furthest, with 12 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.
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 | — |
https://510kreport.com/device/K003909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003909: Proact 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003909
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026