Cleared Traditional

K944567 - COWBOY X

K944567 is an FDA 510(k) clearance for COWBOY X, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K944567 · Kinetic Concepts, Inc. · Cardiovascular device
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Jun 1995
Decision
275d
Days
Class 2
Risk

K944567 is an FDA 510(k) clearance for the COWBOY X. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 275 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.

View all Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K944567

510(k) Number K944567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date June 21, 1995
Days to Decision 275 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
150d slower than avg
Panel avg: 125d · This submission: 275d
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 K944567.
SOF. PRESS EPC 51 SYSTEM
K963067 · Gaymar Industries, Inc. · Jan 1997
MODEL 90022 ROLLING STAND
K963672 · Augustine Medical, Inc. · Jan 1997
REDOX
K953850 · Kinetic Concepts, Inc. · Mar 1996
PRESSSION S III
K942796 · Chattanooga Group, Inc. · Mar 1995
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
K942664 · The Kendal Co. · Jan 1995
SCD(R) CONTROLLER
K933259 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1993