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FDA 510(k)

Sequential Circulator (SC-4004-DL, SC-4008-DL)

K-Number: K261807 · 2026-09-11

ApplicantBio Compression Systems, Inc.
Decision Date2026-09-11
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sequential Circulator (SC-4004-DL, SC-4008-DL) is the device name listed in this FDA 510(k) record. The listed applicant is Bio Compression Systems, Inc.. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K261807. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sequential Circulator (SC-4004-DL, SC-4008-DL)?

Sequential Circulator (SC-4004-DL, SC-4008-DL) is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Bio Compression Systems, Inc.. The 510(k) number is K261807.

When did Sequential Circulator (SC-4004-DL, SC-4008-DL) receive FDA 510(k) clearance?

Sequential Circulator (SC-4004-DL, SC-4008-DL) received FDA 510(k) clearance on 2026-09-11, under 510(k) number K261807.

Who is the listed applicant for Sequential Circulator (SC-4004-DL, SC-4008-DL)?

The FDA 510(k) record lists Bio Compression Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequential Circulator (SC-4004-DL, SC-4008-DL)?

The FDA product code for Sequential Circulator (SC-4004-DL, SC-4008-DL) is JOW.

Other records listing Bio Compression Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250974Bio Arterial Deluxe (IC-BAP-DX)K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLK180248VascuEase IC-1200-WHK171793Sequential Circulator SC-2004FC-OC

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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