Nuwellis, Inc.
Eden Prairie, MN, US
Nuwellis, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Nuwellis, Inc. between 2023 and 2025. The busiest year on record is 2023, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | NQJ | Substantially Equivalent | |
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | NQJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007137787 | 3007137787 | Nuwellis, Inc. | 12988 Valley View Rd, Eden Prairie, MN 55344 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- PNDMidline Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0831-2025 | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients. | Class I | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain