510(k) Report

510(k) · Cleared

Cleared

Kendall SCD 700 Sequential Compression Controller

K120944510(k) TraditionalCleared May 31, 201263-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

Covidien · JOW Sleeve, Limb, Compressible

Cleared on May 31, 2012 as substantially equivalent to K102737 (Covidien, LLC, 2010) after a 63-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.

Decided
May 31, 2012
Review
63 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K953648 (1996). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2013: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant clearedK953648 · 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 · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 1 descendant K102737 · 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. · 19960
  1. Root · 3 generations backK953648 A-V Impulse System Model 6060Novamedix, Ltd. · 1996
  2. 2 generations backK040511 SCD Express Portable Compression SystemTyco Healthcare/Kendall · 2004
  3. 1 generation backK102737 Kendall SCD 700 Sequential Compression ControllerCovidien, LLC · 2010
  4. This deviceK120944 Kendall SCD 700 Sequential Compression ControllerCovidien · 2012
  5. Descendant · cites it directly · 1 of its ownK213577 VenAir, Sequential Compression SystemApex Medical Corp. · 2022
  6. Descendant · cites it directly · 0 of its ownK250242 Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026
  7. Descendant · cites it directly · 0 of its ownK250190 Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd · 2025
  8. Descendant · 2 generations on · 0 of its ownK251466 VenAir, Sequential Compression System (9P-089000); VenAir…Wellell, Inc. · 2025
  9. Descendant · cites it directly · 0 of its ownK131046 Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf)…Venous Health Systems, Inc. · 2013

Most influential descendants

Showing 5 of 5 · See all
  • K213577VenAir, Sequential Compression SystemApex Medical Corp. · 2022 · cites it directly1descendant
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
  • K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd · 2025 · cites it directly0descendants
  • K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…Wellell, Inc. · 2025 · 2 generations on0descendants
  • K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953648A-V Impulse System Model 6060Novamedix, Ltd.1996—
−2K040511SCD Express Portable Compression SystemTyco Healthcare/Kendall2004—
−1K102737Kendall SCD 700 Sequential Compression ControllerCovidien, LLC2010—
0 (this device)K120944Kendall SCD 700 Sequential Compression ControllerCovidien2012—
+1K213577VenAir, Sequential Compression SystemApex Medical Corp.2022—
+1K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.2026—
+1K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd2025—
+2K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential…Wellell, Inc.2025—
+1K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire…Venous Health Systems, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202210
202520
202610
FIG. 1 — Lineage of K120944, 1996–2026Source: 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
*K102737Kendall SCD 700 Sequential Compression Controller
Summary page 1
…Limb Sleeve Device CLASSIFICATION NAME: Sleeve, Limb, Compressible PREDICATE DEVICE(S): Kendall SCDTM 700 Sequential Compression Controller (K102737) DEVICE DESCRIPTION: The Kendall SCD Tm 700 Sequential Compression controller is an…
Covidien, LLC2010—

Also cleared against K102737: 2 other devices →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213577VenAir, Sequential Compression SystemApex Medical Corp.20221
K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.20260
K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd20250
K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, 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 16 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K213577 (Apex Medical Corp., 2022) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K102737.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Kendall SCD™ 700 Sequential Compression System (hereby referenced as “Kendall SCD 700 Series”) is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The Kendall SCD™ 700 Series is a prescription device for use in a clinical setting or in the home. The System consists of the controller, the tubing sets (provided with the…

Read the full statement (204 words)

The Kendall SCD™ 700 Sequential Compression System (hereby referenced as “Kendall SCD 700 Series”) is designed to apply intermittent pneumatic compression to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The Kendall SCD™ 700 Series is a prescription device for use in a clinical setting or in the home.

The System consists of the controller, the tubing sets (provided with the controller) and single-patient use garments (purchased separately from this controller). The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle has reached set pressure, the Controller measures the time it takes for the limbs to refill with blood and waits that period of time before the next compression is initiated.

The use of the Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:

* Deep vein thrombosis and pulmonary embolism prophylaxis.

The use of the Kendall SCD 700 Series Compression System with Foot Cuffs is indicated for:

* Circulation enhancement.

* Deep vein thrombosis prophylaxis.

* Edema - Acute.

* Edema - Chronic.

* Extremity pain incident to trauma or surgery.

* Leg Ulcers.

* Venous stasis / venous insufficiency.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120944: Kendall SCD 700 Sequential Compression Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120944

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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