[8-K] Nuwellis, Inc. Reports Material Event

Rhea-AI Filing Summary

Nuwellis, Inc. announced it received U.S. Food and Drug Administration 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). The filing is brief and states the clearance date as August 21, 2025. This indicates the company added a cleared product variant to its U.S. regulatory portfolio, which may support future clinical use and commercial availability of the dELC family.

The 8-K does not disclose pricing, launch timing, shipment volumes, or expected revenue impact. Investors should note this is a regulatory clearance for a device size variant rather than a new device model and the company provided no operational or financial details in the filing.

Positive

• FDA 510(k) clearance obtained for a new size of the dELC
• Regulatory approval enables U.S. marketing of the new size
• Product-line expansion may improve clinical adoption by matching more patient anatomies

Negative

• No commercial or financial metrics included in the filing to estimate revenue impact
• No launch timeline or distribution plan disclosed in the 8-K
• Clearance is for a size variant, not necessarily a materially new device or market expansion

Insights

Regulatory Affairs Analyst

510(k) clearance adds a cleared size to Nuwellis's dELC product line for U.S. use.

The FDA 510(k) clearance means the new size was found substantially equivalent to a legally marketed predicate device, allowing marketing in the U.S. without a premarket approval pathway.

This clearance may remove a regulatory barrier to commercial distribution of the new size, but the filing provides no launch date, scale, or reimbursement details, so near-term revenue impact is unknown.

Commercial Strategy Expert

Clearance supports product-line expansion but lacks commercialization specifics.

Adding a cleared size to the dELC range can increase clinical fit and buyer adoption where varying catheter lengths matter. However, the 8-K contains no sales, manufacturing, or distribution information, so it is not yet possible to quantify market impact.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 21, 2025

Nuwellis, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-35312	No. 68-0533453
(State or Other Jurisdiction of Incorporation or Organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

12988 Valley View Road, Eden Prairie, MN (Address of Principal Executive Offices) 55344
(Zip Code)

(952) 345-4200

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	NUWE	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01. Other Events.

On August 21, 2025, Nuwellis, Inc. (the “Company”) announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 21, 2025	NUWELLIS, INC.
	By:	/s/ John L. Erb
	Name:	John L. Erb
	Title:	President and Chief Executive Officer

FAQ

What did Nuwellis (NUWE) announce in the August 21, 2025 8-K?

The company announced it received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC) on August 21, 2025.

Does the 8-K state when Nuwellis will begin selling the new dELC size?

No. The 8-K does not provide any launch dates, shipment schedules, or commercialization plans.

Is this FDA action a full approval or a 510(k) clearance for NUWE?

The filing specifies a 510(k) clearance, which is a determination of substantial equivalence to a predicate device, not a premarket approval.

Did Nuwellis disclose expected revenue or financial impact from the clearance?

No. The 8-K contains no financial projections, revenue estimates, or manufacturing details tied to this clearance.

What product was cleared by the FDA according to the filing?

A new size of the Dual Lumen Extended Length Catheter (dELC) was cleared.