Cleared Traditional

K230028 - Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230028 · Cardinal Health200, LLC · Cardiovascular device
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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 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K230028.
Compression Therapy Device (LGT-2202DVT)
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Bio Arterial Deluxe (IC-BAP-DX)
K250974 · Bio Compression Systems, Inc. · Dec 2025
Sequential Compression System (SCD600)
K250190 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · Wellell, Inc. · Oct 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · Manamed, LLC · Sep 2025