Data / Medical devices / United States / Nuwellis, Inc.

Nuwellis, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 4 510(k) clearances

Name: Nuwellis, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nuwellis, Inc. is registered with the FDA (registration 3007137787) in Eden Prairie, MN, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2025. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007137787
Address: 12988 Valley View Rd, Eden Prairie, MN, United States, 55344
Owner or operator: Nuwellis, Inc. (10026935)
Roles: Manufacturer, Specification developer
First device listed: September 22, 2016
Registered through: 2026
Brand names listed: Aquadex FlexFlow, Aquadex Flexflow, Aquadex SmartFlow, dELC

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Hemodialysis, Implanted	MSD	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use	NQJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Manufacturer, Specification developer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer, Specification developer	accessdata.fda.gov
Midline Catheter	PND	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 13, 2025	K252226	Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	NQJ	Substantially Equivalent	Nuwellis, Inc.	accessdata.fda.gov
December 26, 2023	K233515	Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)	NQJ	Substantially Equivalent	Nuwellis, Inc.	accessdata.fda.gov
February 24, 2020	K192756	Aquadex FlexFlow System 2.0	KDI	Substantially Equivalent	Chf Solutions, Inc.	accessdata.fda.gov
September 7, 2007	K071854	AQUADEX FLEXFLOW SYSTEM	KDI	Substantially Equivalent	Chf Solutions, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 11, 2024	95991	Class I	Completed	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 w	accessdata.fda.gov

Compare with other makers

Updated August 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.