510(k) Report

510(k) · Cleared

Cleared

Wright Model 51 and 52 Sequential Compression Systems

K071040510(k) TraditionalCleared May 22, 200740-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 May 22, 2007 as substantially equivalent to K961797 (Wright Linear Pump, Inc., 1996) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.

Decided
May 22, 2007
Review
40 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K830577 (1983). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor2013: 1 descendant clearedK830577 · Linear Pump #4370975 · Wright Linear Pump, Inc. · 1983K961797 · WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II Lite · Wright Linear Pump, Inc. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors 1 generation forward: 1 descendant K961797 · WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II Lite · Wright Linear Pump, Inc. · 1996K830577 · Linear Pump #4370975 · Wright Linear Pump, Inc. · 19830
  1. Root · 2 generations backK830577 Linear Pump #4370975Wright Linear Pump, Inc. · 1983
  2. 1 generation backK961797 WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II LiteWright Linear Pump, Inc. · 1996
  3. This deviceK071040 Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc. · 2007
  4. Descendant · cites it directly · 0 of its ownK131387 Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K830577Linear Pump #4370975Wright Linear Pump, Inc.1983—
−1K961797WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II LiteWright Linear Pump, Inc.1996—
0 (this device)K071040Wright Model 51 and 52 Sequential Compression SystemsWright Linear Pump, Inc.2007—
+1K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199210
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K071040, 1983–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K961797WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II Lite
Summary page 1
…Product Code: JOW, 21 CFR 870.5800 $807.92 (a)(3) Legally Marketed Substantially Equivalent Devices: K961797 Wright Pro-Lite K961292 Wright Solo $807.…
Wright Linear Pump, Inc.1996—
*K961292WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential
Summary page 1
…ally Marketed Substantially Equivalent Devices: K961797 Wright Pro-Lite K961292 Wright Solo $807.92 (a)(4) Description of Device: The Wright 51 and 52 Sequential Compre…
Wright Linear Pump, Inc.1996—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K131387Wright Gradient 52 - TorsoWright Therapy Products, Inc.20130

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?

  • The line of descent spans 24 years and passes through 1 company; a new generation was cleared every 13.5 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K131387 (Wright Therapy Products, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Wright 51 and 52 Sequential Compression System is for treatment of

lymphedema, venous insufficiencies, and other edematous conditions.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K071040: Wright Model 51 and 52 Sequential Compression Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071040

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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