FDA product code NQJ: Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
NQJ is the FDA product code for catheter, hemodialysis, non-implanted, ultrafiltration, for peripheral use. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under NQJ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 89 days (median 62); 28 days on average over the last three years.
Definition
Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for NQJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 55 |
| 2025 | 1 | 28 |
Top NQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nuwellis, Inc. | 2 | 2025-08-13 |
| Chf Solutions, Inc. | 2 | 2004-09-10 |
Most recent NQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252226 | Nuwellis, Inc. | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | 2025-08-13 | 28 |
| K233515 | Nuwellis, Inc. | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | 2023-12-26 | 55 |
| K041791 | Chf Solutions, Inc. | 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | 2004-09-10 | 70 |
| K031689 | Chf Solutions, Inc. | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | 2003-12-23 | 204 |
Recalls for NQJ devices
openFDA lists no recalls for product code NQJ.
Frequently asked questions
What is FDA product code NQJ?
NQJ is the FDA product code for catheter, hemodialysis, non-implanted, ultrafiltration, for peripheral use. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NQJ?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQJ?
Across 4 cleared submissions the average was 89 days from receipt to decision (median 62).
Which companies have the most NQJ clearances?
Nuwellis, Inc. (2); Chf Solutions, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NQJ
- Run a recall and safety report across every NQJ manufacturer
- Watch product code NQJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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