Cleared Traditional

K953850 - REDOX

K953850 is an FDA 510(k) clearance for REDOX, 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 201-day FDA review.

K953850 · Kinetic Concepts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
201d
Days
Class 2
Risk

K953850 is an FDA 510(k) clearance for the REDOX. 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 March 4, 1996 after a review of 201 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 - K953850

510(k) Number K953850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date March 04, 1996
Days to Decision 201 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
76d slower than avg
Panel avg: 125d · This submission: 201d
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 329
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K953850.
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M.I.C.
K950967 · V.V.T. Healthcare Technologies, Inc. · May 1996
ART-ASSIST MODEL AA-1000
K942530 · Aci Medical, Inc. · Feb 1996
TRINITY SLEEVE(S)
K954489 · Delphi Consulting Group · Feb 1996
A-V IMPULSE SYSTEM MODEL 6060
K953648 · Novamedix , Ltd. · Feb 1996