# K230028: 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

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Apr 3, 2023 after 89 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 13, 2025 · Class II · Z-1919-2025: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- May 13, 2025 · Class II · Z-1918-2025: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- May 13, 2025 · Class II · Z-1917-2025: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

## Indications for use
Intended Use The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the controller, the tubing assemblies (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, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate. The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals. Indications Leg Compression The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for: * Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis. * Treatment of pain and swelling related to venous stasis * Circulation enhancement The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for: * Deep Vein Thrombosis Prophylaxis. Foot Compression The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for: * Circulation Enhancement * Deep Vein Thrombosis Prophylaxis * Edema - Acute * Edema - Chronic * Extremity Pain Incident to Trauma or Surgery * Leg Ulcers * Venous Stasis

Source page: https://510kreport.com/device/K230028
Methodology: https://510kreport.com/methodology