Cleared Traditional

M.I.C. (K950967) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950967 · V.V.T. Healthcare Technologies, Inc. · Cardiovascular device
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May 1996
Decision
447d
Days
Class 2
Risk

K950967 is an FDA 510(k) clearance for the M.I.C.. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by V.V.T. Healthcare Technologies, Inc. (Clarkston, US). The FDA issued a Cleared decision on May 8, 1996 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all V.V.T. Healthcare Technologies, Inc. devices

Submission Details

510(k) Number K950967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1995
Decision Date May 08, 1996
Days to Decision 447 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 125d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 86
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K950967.
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PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · 3M Company · Nov 1979