510(k) · Cleared
ClearedDual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuwellis, Inc. · NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Cleared on Aug 13, 2025 as substantially equivalent to K233515 (Nuwellis, Inc., 2023) after a 28-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Aug 13, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- NQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861479 (1986). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK861479 Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
- 4 generations backK971999 Peripherally Inserted CentralB.Braun Medical, Inc. · 1997
- 3 generations backK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
- 2 generations backK041791 5.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004
- 1 generation backK233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual…Nuwellis, Inc. · 2023
- This deviceK252226 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual…Nuwellis, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861479 | Cavafix, Central Venous Catheter Kit | Burron Medical Products, Inc. | 1986 | — |
| −4 | K971999 | Peripherally Inserted Central | B.Braun Medical, Inc. | 1997 | — |
| −3 | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
| −2 | K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2004 | — |
| −1 | K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen… | Nuwellis, Inc. | 2023 | — |
| 0 (this device) | K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen… | Nuwellis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQJ device
- #1 K233515 Dual Lumen Extended Length Catheter (dELC)…score 10.5 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm NQJ… | 2023 |
| † | K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc) | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All NQJ devicesNQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NQJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQJ
Too few NQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NQJ
No recall names NQJ since 2007.
Adverse event reports per year · NQJ
2in 2022
MAUDE reports naming product code NQJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use.The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252226 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252226: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252226
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026