Sequential Circulator (SC-4004-DL, SC-4008-DL)— 510(k) K261807
Substantially EquivalentBio Compression Systems, Inc.
FDA 510(k) clearance K261807 for Sequential Circulator (SC-4004-DL, SC-4008-DL), Substantially Equivalent on 2026-09-11. Applicant: Bio Compression Systems, Inc.. Device class: 2.
Summary
The Sequential Circulator (models SC-4004-DL and SC-4008-DL) is filed under JOW, compressible limb sleeves. The record doesn't describe how it works or what it's used for.
Class II, 21 CFR 870.5800. The Cardiovascular panel reviewed it as a Traditional 510(k).
Bio Compression Systems filed from Moonachie, New Jersey. Review took 102 days (June 1 to September 11, 2026).
Clearance details
- Applicant
- Bio Compression Systems, Inc.
- Product code
- Product code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Moonachie, NJ, US
Recent devices under product code JOW
view allMore clearances from Bio Compression Systems, Inc.
view all- K250974 — Bio Arterial Deluxe (IC-BAP-DX)
- K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K180248 — VascuEase IC-1200-WH
- K171793 — Sequential Circulator SC-2004FC-OC
Data sourced from openFDA. This site is unofficial and independent of the FDA.