Cleared Traditional

K920308 - COWBOY II

K920308 is an FDA 510(k) clearance for COWBOY II, 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 214-day FDA review.

K920308 · Kinetic Concepts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
214d
Days
Class 2
Risk

K920308 is an FDA 510(k) clearance for the COWBOY II. 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 August 24, 1992 after a review of 214 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 - K920308

510(k) Number K920308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1992
Decision Date August 24, 1992
Days to Decision 214 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 125d · This submission: 214d
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 K920308.
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE
K932835 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1993
COWBOY III
K932215 · Kinetic Concepts, Inc. · Jul 1993
PRESSSION, SEQUENTIAL
K921608 · Chattanooga Group, Inc. · Dec 1992
COWBOY
K913611 · Kinetic Concepts, Inc. · Jan 1992
PULSATILE ANTI-EMBOLISM SYS.PUMP
K911853 · Baxter Healthcare Corp · Jul 1991
FLOWPLUS AC330 PUMP GARMENTS
K910188 · Huntleigh Technology, Inc. · May 1991