Cleared Traditional

K061967 - SCD GARMENT, MODEL VP530

K061967 is an FDA 510(k) clearance for SCD GARMENT, manufactured by Compression Therapy Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K061967 · Compression Therapy Concepts, Inc. · Cardiovascular device
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Sep 2006
Decision
75d
Days
Class 2
Risk

K061967 is an FDA 510(k) clearance for the SCD GARMENT, MODEL VP530. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Compression Therapy Concepts, Inc. (Wanamassa, US). The FDA issued a Cleared decision on September 25, 2006 after a review of 75 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.

FDA 510(k) Submission Details - K061967

510(k) Number K061967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2006
Decision Date September 25, 2006
Days to Decision 75 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 125d · This submission: 75d
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 342
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K061967.
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K061967 · SCD GARMENT, MODEL VP530
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