510(k) K230028 ยท JOW Sleeve, Limb, Compressible
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
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Apr 3, 2023 |
| Received | Jan 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2025 | Cardinal Health 200, LLC SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Completed |
JOW | None listed |
| Jun 6, 2025 | Cardinal Health 200, LLC 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 Completed |
JOW | None listed |
| Jun 6, 2025 | Cardinal Health 200, LLC 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 Completed |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.