Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210417 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
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 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, and SC-4008-DL are Sleeve, Limb, Compressible devices designed to improve venous return and circulation in limbs through sequential compression. These devices apply rhythmic pressure to the limb to enhance blood flow, reducing the risk of complications such as deep vein thrombosis (DVT) and edema, particularly in postoperative or immobilized patients.
These devices are intended for single-use and are supplied sterile, requiring no additional preparation before use. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD). Available in multiple sizes (SC-1004-DL, SC-1008-DL, etc.), they are designed for use in cardiovascular settings, such as hospitals and clinical environments. No MRI safety information is specified, and they are authorized under FDA 510K clearance and MDD compliance.
Frequently asked questions
Are these sequential circulators designed for reuse or are they single-use devices?
These devices are explicitly intended for single-use only. The manufacturer states they are supplied sterile and require no additional preparation before use, which aligns with single-use design principles.
What sizes or models are available for the Sequential Circulators, and how do I determine which one to choose?
Six models are available: SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, and SC-4008-DL. The numerical differences (e.g., 1004 vs. 2008) likely correspond to variations in length and compression settings, but the exact sizing criteria (e.g., limb circumference or length) are not detailed in the provided data. Clinicians should refer to the manufacturer’s sizing guidelines or consult with their technical support for proper model selection.
How should these devices be stored before use, and what are the shelf-life considerations?
The devices are supplied sterile, but specific storage instructions (e.g., temperature, humidity, or expiration timing) are not provided in the data. Generally, sterile single-use devices should be stored in a clean, dry environment away from direct sunlight until use. For precise storage and expiration details, refer to the manufacturer’s instructions or packaging.
Are these devices compatible with MRI environments, and if not, why?
The data does not specify MRI safety information for these devices, meaning their compatibility with MRI environments is not confirmed. Since they are designed for cardiovascular use in hospitals, clinicians should assume they may not be MRI-safe unless explicitly labeled otherwise. Always verify with the manufacturer or facility protocols before use in an MRI setting.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
These devices are authorized under FDA 510K clearance and comply with the Medical Device Directive (MDD). They are classified as Class II devices under FDA regulations, indicating a moderate level of regulatory oversight. This means they have undergone premarket review to ensure safety and effectiveness for their intended use—sequential compression to improve venous return in limbs—while still requiring adherence to clinical guidelines and facility protocols.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210417 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
Sources (2)
- FDA 510(k) K210417 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026