510(k) Report

510(k) · Cleared

Cleared

VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

K251466510(k) SpecialCleared Oct 28, 2025168-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

Wellell, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Oct 28, 2025 as substantially equivalent to K213577 (Apex Medical Corp., 2022) after a 168-day review. Its family tree reaches back 5 generations to 1996.

Decided
Oct 28, 2025
Review
168 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K953648 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK953648 · A-V Impulse System Model 6060 · Novamedix, Ltd. · 1996K040511 · SCD Express Portable Compression System · Tyco Healthcare/Kendall · 2004K102737 · Kendall SCD 700 Sequential Compression Controller · Covidien, LLC · 2010K120944 · Kendall SCD 700 Sequential Compression Controller · Covidien · 2012K213577 · VenAir, Sequential Compression System · Apex Medical Corp. · 20221995200020052010201520202025
Other ancestors, by generation 5 generations back: 1 other ancestor K213577 · VenAir, Sequential Compression System · Apex Medical Corp. · 2022K120944 · Kendall SCD 700 Sequential Compression Controller · Covidien · 2012K102737 · Kendall SCD 700 Sequential Compression Controller · Covidien, LLC · 2010K040511 · SCD Express Portable Compression System · Tyco Healthcare/Kendall · 2004K953648 · A-V Impulse System Model 6060 · Novamedix, Ltd. · 1996−50
  1. Root · 5 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  2. 4 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
  3. 3 generations backK102737 Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
  4. 2 generations backK120944 Kendall SCD 700 Sequential Compression ControllerCovidien · 2012
  5. 1 generation backK213577 VenAir, Sequential Compression SystemApex Medical Corp. · 2022
  6. This deviceK251466 VenAir, Sequential Compression System (9P-089000); VenAir…Wellell, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K953648A-V Impulse System Model 6060Novamedix, Ltd.1996—
−4K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall2004—
−3K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC2010—
−2K120944Kendall SCD 700 Sequential Compression ControllerCovidien2012—
−1K213577VenAir, Sequential Compression SystemApex Medical Corp.2022—
0 (this device)K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential…Wellell, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K251466, 1996–2025Source: 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
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What was it cleared against? (1)

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
*K213577VenAir, Sequential Compression System
Summary page 5
…e limb sleeve Product Code: JOW Device Class: Class II 5. Identification of the predicate device 510(k) Number: K213577 Predicate Trade Name: VenAir, Sequential Compression System Applicant: Apex Medical Corp. Regu…
Apex Medical Corp.2022—

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?

  • The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 6.3 years on median.
  • None of the 6 ancestors has a recall.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.

Indications for use as stated in the FDA summary.

More from Wellell, Inc.

2 FDA decisions under this applicant name. See the company

  • K243023WiZARD 520 Full Face MaskWellell, Inc. · 2025

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/K251466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251466: VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251466

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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