Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly

FDA 510(k) K230028 · Cardinal Health200, LLC

Substantially Equivalent

510(k) numberK230028

Submission

Device name
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
Applicant
Cardinal Health200, LLC
Waukegan, IL, US
Received
January 4, 2023
Decision date
April 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional Tactile Medical07/31/2026SE
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K250242Compression Therapy Device (LGT-2202DVT)JOW · Traditional Guangzhou Longest Medical Technology Co., Ltd.04/24/2026SE
K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special Manamed, LLC09/17/2025SE

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Questions and answers

When was Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly cleared by the FDA?

Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (K230028) received a 510(k) decision of Substantially Equivalent on April 3, 2023, 89 days after the submission was received.

What is the product code of K230028?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.