510(k) · Cleared
ClearedDual 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 Dec 23, 2003 as substantially equivalent to K013733 (Chf Solutions, Inc., 2002) and 3 other predicates after a 204-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 204 days
- Class
- Class II
- Product code
- NQJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K861479 (1986). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK861479 Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
- 1 generation backK971999 Peripherally Inserted CentralB.Braun Medical, Inc. · 1997
- This deviceK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK041791 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 3 of 3 · See all- K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004 · cites it directly2descendants
- K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc. · 2023 · cites it directly1descendant
- K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861479 | Cavafix, Central Venous Catheter Kit | Burron Medical Products, Inc. | 1986 | — |
| −1 | K971999 | Peripherally Inserted Central | B.Braun Medical, Inc. | 1997 | — |
| 0 (this device) | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
| +1 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K013733 | System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set | 2002 |
| * | K971999 | Peripherally Inserted CentralSummary page 1…· Product code: KDI · Product code: MPB Predicate * CHF Solutions, System 100, · B. Braun Accuguide® (K971999) Devices: Extended Length Catheter (KO13733) · meoComp® VASCU-PICC TM… | 1997 |
| * | K030270 | 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc…Summary page 1…) Devices: Extended Length Catheter (KO13733) · meoComp® VASCU-PICC TM (K030270) and Duo-Flow TM (K974236) Device The dEL… | 2003 |
| * | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL…Summary page 1…(K030270) and Duo-Flow TM (K974236) Device The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is Description: in… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K041791 (Chf Solutions, Inc., 2004) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K013733.
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 Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100.
The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
The 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/K031689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031689: 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/K031689
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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