Cleared Traditional

K043423 - MODEL SC-3008 SEQUENTIAL CIRCULATOR

K043423 is an FDA 510(k) clearance for MODEL SC-3008 SEQUENTIAL CIRCULATOR, 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 50-day FDA review.

K043423 · Bio Compression Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
50d
Days
Class 2
Risk

K043423 is an FDA 510(k) clearance for the MODEL SC-3008 SEQUENTIAL CIRCULATOR. 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 February 1, 2005 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio Compression Systems, Inc. devices

FDA 510(k) Submission Details - K043423

510(k) Number K043423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date February 01, 2005
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 121
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K043423.
REPROCESSED COMPRESSION SLEEVES
K060049 · Alliance Medical Corp. · Feb 2006
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
K060091 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002