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— 510(k) K230028
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K230028 for 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, Substantially Equivalent on 2023-04-03. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health200, LLC
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code JOW
view allMore clearances from Cardinal Health200, LLC
view all- K241780 — Cardinal Health Nitrile Exam Gloves
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more
- K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
- K211390 — Nitrile Blue Powder-free Examination Glove
Recalls naming K230028
K-number listed on FDA's recall record- Z-1917-2025 — SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Z-1918-2025 — Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Z-1919-2025 — Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230028.
Data sourced from openFDA. This site is unofficial and independent of the FDA.