510(k) Report

510(k) · Cleared

Cleared

WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential

K961292510(k) TraditionalCleared Nov 6, 1996216-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wright Linear Pump, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Nov 6, 1996 as substantially equivalent to K830577 (Wright Linear Pump, Inc., 1983) and 3 other predicates after a 216-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.

Decided
Nov 6, 1996
Review
216 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K830577 (1983). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor2007: 1 descendant cleared2013: 1 descendant clearedK830577 · Linear Pump #4370975 · Wright Linear Pump, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K830577 · Linear Pump #4370975 · Wright Linear Pump, Inc. · 19830
  1. Root · 1 generation backK830577 Linear Pump #4370975Wright Linear Pump, Inc. · 1983
  2. This deviceK961292 WLP Sequential Version Model WLP Solo VI, WLP Solo SequentialWright Linear Pump, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK071040 Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007
  4. Descendant · 2 generations on · 0 of its ownK131387 Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007 · cites it directly1descendant
  • K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830577Linear Pump #4370975Wright Linear Pump, Inc.1983—
0 (this device)K961292WLP Sequential Version Model WLP Solo VI, WLP Solo SequentialWright Linear Pump, Inc.1996—
+1K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc.2007—
+2K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201310
FIG. 1 — Lineage of K961292, 1983–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K830577Linear Pump #4370975
Summary page 1
…................ 74J0W 4.3. equivalence 4.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh v/ Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 20…
Wright Linear Pump, Inc.1983—
*K871271Huntleigh Flowpress AC300 Pump, SQ301/302/320 Gar.
Summary page 1
…he proposed device is similar in design, function, and composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh v/ Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion…
Huntleigh Technology, Inc.1987—
*K874688Flowtron AC200/2
Summary page 1
…composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh v/ Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion sequential). 43.1.1. As a sequential pressure system…
Huntleigh Technology, Inc.1988—
*K921608Presssion, Sequential
Summary page 1
…h as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh v/ Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion sequential). 43.1.1. As a sequential pressure system, the proposed device is simpler than existing gradie…
Chattanooga Group, Inc.1992—

Also cleared against K830577: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc.20071

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 4 ancestors has a recall.
  • Of its descendants, K071040 (Wright Linear Pump, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K830577.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

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.

Also cleared against K830577

2 other devices cite the same predicate.

  • K013436Normatec PCDNormatec, Inc. · 2001
  • K961797WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II LiteWright Linear Pump, Inc. · 1996

More from Wright Linear Pump, Inc.

6 FDA decisions under this applicant name. See the company

  • K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007
  • K961797WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II LiteWright Linear Pump, Inc. · 1996
  • K961891WLP Single-Segment Version WLP Solo ViiWright Linear Pump, Inc. · 1996
  • K883186Wright Gradient Pressure Support StockingsWright Linear Pump, Inc. · 1988
  • K830577Linear Pump #4370975Wright Linear Pump, Inc. · 1983

Recent decisions in JOW

The JOW category page

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K254217AerloomEvolym, LLC · 2026
  • K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
  • K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K961292 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961292: WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961292

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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