Cleared Traditional

K261807 - Sequential Circulator (SC-4004-DL, SC-4008-DL)

K261807 is an FDA 510(k) clearance for Sequential Circulator (SC-4004-DL, manufactured by Bio Compression Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K261807 · Bio Compression Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
102d
Days
Class 2
Risk

K261807 is an FDA 510(k) clearance for the Sequential Circulator (SC-4004-DL, SC-4008-DL). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Moonachie, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio Compression Systems, Inc. devices

FDA 510(k) Submission Details - K261807

510(k) Number K261807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2026
Decision Date September 11, 2026
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 316
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K261807.
Flexitouch® Plus Advanced Pneumatic Compression System
K253555 · Tactile Medical · Jul 2026
DVT Garment
K253386 · Vistar Medical Supplies Co., Ltd. · Jun 2026
Compression Therapy Device (LGT-2202DVT)
K250242 · Guangzhou Longest Medical Technology Co., Ltd. · Apr 2026
NanoPress 760A-BT (760A-BT)
K254267 · Mego Afek , Ltd. · Feb 2026
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · Bio Compression Systems, Inc. · Dec 2025
Sequential Compression System (SCD600)
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025