510(k) · Cleared
ClearedMultipulse Sequential Compression Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talley Group, Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Feb 11, 1992 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 32 later devices descend from it.
- Decided
- Feb 11, 1992
- Review
- 111 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 3 citing it directly.
- This deviceK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
- Descendant · cites it directly · 30 of its ownK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
- Descendant · 2 generations on · 14 of its ownK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
- Descendant · 3 generations on · 13 of its ownK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
- Descendant · 2 generations on · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K013061Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002 · cites it directly30descendants
- K080134Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)Wonjin Mulsan Co., Ltd. · 2009 · 2 generations on14descendants
- K100656Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010 · 3 generations on13descendants
- K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · 2 generations on10descendants
- K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914774 | Multipulse Sequential Compression Unit | Talley Group, Ltd. | 1992 | — |
| +1 | K013061 | Biotouch Massage Therapy System | Tactile Systems Technology, Inc. | 2002 | — |
| +2 | K080134 | Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000) | Wonjin Mulsan Co., Ltd. | 2009 | — |
| +3 | K100656 | Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus) | Wonjin Mulsan Co., Ltd. | 2010 | — |
| +2 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| +2 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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? (32)
See all 323 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, K013061 (Tactile Systems Technology, Inc., 2002) has gone furthest, with 30 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/K914774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914774: Multipulse Sequential 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/K914774
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026