Cleared Traditional

K981311 - COWBOY XV

K981311 is an FDA 510(k) clearance for COWBOY XV, manufactured by Kci New Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K981311 · Kci New Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
378d
Days
Class 2
Risk

K981311 is an FDA 510(k) clearance for the COWBOY XV. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Kci New Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 23, 1999 after a review of 378 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Kci New Technologies, Inc. devices

FDA 510(k) Submission Details - K981311

510(k) Number K981311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date April 23, 1999
Days to Decision 378 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
253d slower than avg
Panel avg: 125d · This submission: 378d
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 153
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K981311.
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · The Kendall Company, L.P. · Sep 1999
WALKCARE P200 SYSTEM
K973592 · A.Stein - Regulatory Affairs Consulting · May 1999
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · Delphi Consulting Group · Apr 1999
VASO PRESS SYSTEM
K974393 · Britt Corp., Inc. · Mar 1999
RTM DVT PROSOFT CUFF MODEL NUMBER PS100
K981643 · R.T. Medical Services, Inc. · Dec 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · Dideco S.P.A. · Aug 1998