510(k) · Cleared
ClearedHuntleigh FP5000 System Model FP5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Jan 26, 1998 after a 399-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 24 later devices descend from it.
- Decided
- Jan 26, 1998
- Review
- 399 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
24 later devices descend from it, 2 citing it directly.
- This deviceK965153 Huntleigh FP5000 System Model FP5000Huntleigh Healthcare, Inc. · 1998
- Descendant · cites it directly · 22 of its ownK061857 Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006
- Descendant · 2 generations on · 18 of its ownK072666 Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007
- Descendant · 3 generations on · 14 of its ownK131327 Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013
- Descendant · 4 generations on · 12 of its ownK181149 Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018
- Descendant · 5 generations on · 11 of its ownK190854 Therm-XZenith Technical Innovations · 2019
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 2006 · cites it directly22descendants
- K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2007 · 2 generations on18descendants
- K131327Bioarterial Plus Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 2013 · 3 generations on14descendants
- K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations · 2018 · 4 generations on12descendants
- K190854Therm-XZenith Technical Innovations · 2019 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965153 | Huntleigh FP5000 System Model FP5000 | Huntleigh Healthcare, Inc. | 1998 | — |
| +1 | K061857 | Model Multi-Flo IC-1545-KT/-F Intermittent Circulator | Bio Compression Systems, Inc. | 2006 | — |
| +2 | K072666 | Bioarterial Plus, Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2007 | — |
| +3 | K131327 | Bioarterial Plus Arterial Blood Flow Enhancement System | Bio Compression Systems, Inc. | 2013 | — |
| +4 | K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations | 2018 | — |
| +5 | K190854 | Therm-X | Zenith Technical Innovations | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 JOW? 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 JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | Kendall | AV5000 System Number could not be read Summary page 1…imen for venous and arterial conditions of the lower limbs. The system is designed to provide therapy comparable to existing marketed devices such as the AV5000 system (Kendall) and the PlexiPulse system (NuTech/KCI). There are no changesto ! the claims, intended use, clinical applications, patient popula… | |
| * | — | PlexiPulse system Named without a submission number |
What descends from it? (24)
See all 242 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, K061857 (Bio Compression Systems, Inc., 2006) has gone furthest, with 22 descendants of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
Prevention of deep vein thrombosis
Enhancement of venous & arterial circulation
Prevention of venous stasis
Assist healing of cutaneous ulcers
Reduction of acute or chronic edema
Reduction of lower limb pain due to surgery or trauma
Reduction of compartmental pressures
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/K965153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965153: Huntleigh FP5000 System Model FP5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965153
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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