Cleared Traditional

K210417 - Sequential Circulators SC-1004-DL

K210417 is an FDA 510(k) clearance for Sequential Circulators SC-1004-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 92-day FDA review.

K210417 · Bio Compression Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
92d
Days
Class 2
Risk

K210417 is an FDA 510(k) clearance for the Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-400.... 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 May 14, 2021 after a review of 92 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 - K210417

510(k) Number K210417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2021
Decision Date May 14, 2021
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 120
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K210417.
CIRCUL8 Luxe DVT Prevention Device
K211235 · Ortho8, Inc. · Sep 2021
WoundExpress
K211200 · Huntleigh Healthcare , Ltd. · Sep 2021
PlasmaWave
K211253 · Manamed, Inc. · May 2021
Reprocessed Tri Pulse Compression Garment
K203847 · Renu Medical, Inc. · May 2021
Dayspring
K210885 · Koya Medical, Inc. · Apr 2021
DVT-PRO
K203353 · Daesung Maref Co., Ltd. · Apr 2021