Cleared Traditional

K230028 - Kendall SCD SmartFlow Controller

K230028 is the FDA 510(k) clearance for Kendall SCD SmartFlow Controller by Cardinal Health200, LLC. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K230028 · Cardinal Health200, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
89d
Days
Class 2
Risk

K230028 is an FDA 510(k) clearance for the Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SC.... Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on April 3, 2023 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health200, LLC devices

Submission Details

510(k) Number K230028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2023
Decision Date April 03, 2023
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 113
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K230028.
MedHealth DVT compression Devices MHH900S/MHH900E
K231801 · Medhealth Medical Limited · Dec 2023
AeroDVx Arm System
K222823 · Sun Scientific, Inc. · Sep 2023
LEGACY® IPC
K232006 · Ig Technology, Ltd. · Aug 2023
Capiflo 5001
K222158 · K&L Distributing, Inc. · Jan 2023
AIROS 8P Sequential Compression Device
K223193 · Airos Medical, Inc. · Dec 2022
AIROS 6P Sequential Compression Device
K223195 · Airos Medical, Inc. · Dec 2022