510(k) · Cleared
ClearedTalley TM200 Intermttent Compression Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progressive Medical Technology, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Feb 11, 1992 after a 56-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 48 later devices descend from it.
- Decided
- Feb 11, 1992
- Review
- 56 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 3 citing it directly.
- This deviceK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
- Descendant · cites it directly · 31 of its ownK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
- Descendant · 2 generations on · 30 of its ownK061125 Dvtcare CA5Doctors Orders · 2006
- Descendant · 2 generations on · 25 of its ownK103187 Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011
- Descendant · 2 generations on · 22 of its ownK133274 Vena ProInnovamed Health, LLC · 2014
- Descendant · cites it directly · 14 of its ownK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K022340Travelair Portable Compression SystemDynamic Air, Inc. · 2003 · cites it directly31descendants
- K061125Dvtcare CA5Doctors Orders · 2006 · 2 generations on30descendants
- K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc. · 2011 · 2 generations on25descendants
- K133274Vena ProInnovamed Health, LLC · 2014 · 2 generations on22descendants
- K080134Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)Wonjin Mulsan Co., Ltd. · 2009 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915638 | Talley TM200 Intermttent Compression Unit | Progressive Medical Technology, Inc. | 1992 | — |
| +1 | K022340 | Travelair Portable Compression System | Dynamic Air, Inc. | 2003 | — |
| +2 | K061125 | Dvtcare CA5 | Doctors Orders | 2006 | — |
| +2 | K103187 | Tripleplay-VT Vascular Therapy System | Wildcat Medical, Inc. | 2011 | — |
| +2 | K133274 | Vena Pro | Innovamed Health, LLC | 2014 | — |
| +1 | K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (48)
See all 483 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, K022340 (Dynamic Air, Inc., 2003) has gone furthest, with 31 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/K915638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915638: Talley TM200 Intermttent Compression Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915638
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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