Cleared Traditional

K964188 - HEALTHCARE SERVICE AND SUPPLY PVA (PNEU...

K964188 is an FDA 510(k) clearance for HEALTHCARE SERVICE AND SUPPLY PVA (PNEU..., manufactured by Healthcare Service and Supply. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K964188 · Healthcare Service and Supply · Cardiovascular device
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May 1997
Decision
197d
Days
Class 2
Risk

K964188 is an FDA 510(k) clearance for the HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Healthcare Service and Supply (Tustin, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K964188

510(k) Number K964188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date May 06, 1997
Days to Decision 197 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
72d slower than avg
Panel avg: 125d · This submission: 197d
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 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K964188.
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REDOX
K953850 · Kinetic Concepts, Inc. · Mar 1996