Cleared Special

K171793 - Sequential Circulator SC-2004FC-OC

K171793 is an FDA 510(k) clearance for Sequential Circulator SC-2004FC-OC, manufactured by Bio Compression Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 62-day FDA review.

K171793 · Bio Compression Systems, Inc. · Cardiovascular device
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Aug 2017
Decision
62d
Days
Class 2
Risk

K171793 is an FDA 510(k) clearance for the Sequential Circulator SC-2004FC-OC. 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 August 17, 2017 after a review of 62 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio Compression Systems, Inc. devices

FDA 510(k) Submission Details - K171793

510(k) Number K171793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2017
Decision Date August 17, 2017
Days to Decision 62 days
Submission Type Special
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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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
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