Device (SC-3004-DL Sequential Circulator +3 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K142640

Identifiers

510(k) Number: K142640 FDA 510(k)
FDA Product Code: JOW FDA 510(k)
Models / Variants: SC-3004-DL Sequential Circulator FDA 510(k)EUDAMED
Model SC-3004FC-DL Sequenstial Circulator FDA 510(k)EUDAMED
Model SC-2008-DL Sequential Circulator FDA 510(k)EUDAMED
Model SC-3008-DL Sequential Circulator FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.5800 FDA 510(k)
Regulation Number: 870.5800 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The device is a Sleeve, Limb, Compressible, classified as a Class II medical device under FDA regulations. It functions as a sequential circulator designed to apply pneumatic compression to limbs, facilitating lymphatic and venous return. These devices are intended for use in the treatment of primary or secondary lymphedema by promoting fluid drainage through controlled, sequential pressure cycles across multiple chambers in the compression sleeve.

The sequential circulators are supplied as reusable pneumatic devices, paired with disposable compression sleeves. They operate in clinical settings such as outpatient therapy or home use, adhering to FDA 510(k) clearance and MDD compliance. Each model (SC-3004-DL, SC-3004FC-DL, SC-2008-DL, SC-3008-DL) features calibrated gradient pressure adjustments, with chamber configurations tailored for limb-specific therapy. No MRI safety or sterility requirements are specified, and devices must be maintained per manufacturer instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bio Compression Systems SC-3004-DL Operating Instructions Manual, Bio compression systems SC-3004-DL Manuals | ManualsLib, Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial ..., BioCompression SC-3004 Four Chamber Sequential Circulator

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K142640	Class II	Active

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Manufacturer

Manufacturer: Bio Compression Systems, Inc.

Sources (2)

FDA 510(k) K142640 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced May 19, 2026