510(k) · Cleared
Cleared5.2F Dual Lumen Extended Length Catheter (Delc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chf Solutions, Inc. · NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Cleared on Sep 10, 2004 as substantially equivalent to K031689 (Chf Solutions, Inc., 2003) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- NQJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K861479 (1986). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK861479 Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
- 2 generations backK971999 Peripherally Inserted CentralB.Braun Medical, Inc. · 1997
- 1 generation backK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
- This deviceK041791 5.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual…Nuwellis, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252226 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual…Nuwellis, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861479 | Cavafix, Central Venous Catheter Kit | Burron Medical Products, Inc. | 1986 | — |
| −2 | K971999 | Peripherally Inserted Central | B.Braun Medical, Inc. | 1997 | — |
| −1 | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 K252226 Dual Lumen Extended Length Catheter (dELC)…score 11.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K031689 | Dual Lumen Extended Length Catheter (Delc) Our reading of the summary gave K031869, FDA’s number for Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical… (Surgical Instruments Service and Savings, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “CHF Solutions, 6F dELC”. | 2003 |
| * | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration SetSummary page 1…Product code: MPB Predicate CHIF Solutions, 6F dELC (K031869) Devices: CHF Solutions, Extended Length Catheter (K013733) Device The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is Description:… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended… | 2023 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K233515 (Nuwellis, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031689.
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.
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 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the
basilic vein (arm) and antecubital region respectively and specifically for use with the
Aquadex TM System 100 when the blood flow rate is set at <20ml/minute.
The catheter is not intended for the infusion of medications or fluids, for laboratory
sampling, or other venous access needs.
The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment
of patients with fluid overload.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041791: 5.2F Dual Lumen Extended Length Catheter (Delc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041791
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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