510(k) · Cleared
ClearedWLP Single-Segment Version WLP Solo Vii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Linear Pump, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Nov 6, 1996 as substantially equivalent to K874688 (Huntleigh Technology, Inc., 1988) and 1 other predicate after a 181-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 6, 1996
- Review
- 181 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K882683 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882683 Jobst Extremity Pump (R) System 7500Jobst Institute, Inc. · 1988
- This deviceK961891 WLP Single-Segment Version WLP Solo ViiWright Linear Pump, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882683 | Jobst Extremity Pump (R) System 7500 | Jobst Institute, Inc. | 1988 | — |
| 0 (this device) | K961891 | WLP Single-Segment Version WLP Solo Vii | Wright Linear Pump, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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? (3)
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 |
|---|---|---|---|
| * | K874688 | Flowtron AC200/2Summary page 1…............... 74JOW 5.3. equivalence 5.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K874688 Huntleigh Flowtron AC200/2, document K882683 Jobst Extremity Pump System 7000, and document K814775 Talley MicroSystem/Talley. 5… | 1988 |
| * | K882683 | Jobst Extremity Pump (R) System 7500Summary page 1…1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K874688 Huntleigh Flowtron AC200/2, document K882683 Jobst Extremity Pump System 7000, and document K814775 Talley MicroSystem/Talley. 5.3.1.1. As a single pressure system, the prop… | 1988 |
| Kept off the family tree | K814775 | Talley MicroSystem/Talley Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…and composition to existing compression pump devices such as document K874688 Huntleigh Flowtron AC200/2, document K882683 Jobst Extremity Pump System 7000, and document K814775 Talley MicroSystem/Talley. 5.3.1.1. As a single pressure system, the proposed device is simpler than existing sequential pressur… |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K874688.
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?
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
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/K961891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961891: WLP Single-Segment Version WLP Solo Vii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961891
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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