Cleared Special

K070324 - IPC-BOOT

K070324 is an FDA 510(k) clearance for IPC-BOOT, manufactured by C-Boot , Ltd.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Special 510(k) pathway after a 87-day FDA review.

K070324 · C-Boot , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
87d
Days
Class 2
Risk

K070324 is an FDA 510(k) clearance for the IPC-BOOT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by C-Boot , Ltd. (Carmiel, IL). The FDA issued a Cleared decision on May 3, 2007 after a review of 87 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 C-Boot , Ltd. devices

FDA 510(k) Submission Details - K070324

510(k) Number K070324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2007
Decision Date May 03, 2007
Days to Decision 87 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 168
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