FDA product code NIE: Catheter, Hemodialysis, Triple Lumen, Non-Implanted
NIE is the FDA product code for catheter, hemodialysis, triple lumen, non-implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under NIE, 2 in the last five years, from 7 different applicants. The average 510(k) review took 190 days (median 191). FDA has posted 38 recalls for NIE devices, 35 initiated in the last five years.
Definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, Triple Lumen, Non-Implanted |
| 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 NIE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 64 |
| 2019 | 1 | 206 |
| 2023 | 2 | 116 |
Compare with all 510(k) review times · Search every NIE clearance
Top NIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Components, Inc. (dba MedComp) | 3 | 2023-11-16 |
| C.R. Bard, Inc. | 3 | 2015-06-01 |
| Medcomp | 2 | 2013-06-11 |
| Health Line International Corporation | 1 | 2023-01-13 |
| Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 1 | 2015-07-24 |
2 more applicants have NIE clearances. See the full list in Caduvo.
Most recent NIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232945 | Medical Components, Inc. (dba MedComp) | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | 2023-11-16 | 57 |
| K222170 | Health Line International Corporation | Power Acute Triple Lumen Hemodialysis Catheter | 2023-01-13 | 176 |
| K183219 | Medical Components, Inc. (dba MedComp) | Trio-CT Triple Lumen Catheter | 2019-06-14 | 206 |
| K181175 | Medical Components, Inc. (dba MedComp) | 12F Tri-Flow Triple Lumen Catheter | 2018-07-05 | 64 |
| K143102 | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | 2015-07-24 | 268 |
Recalls for NIE devices
38 product recalls in 8 recall events; 35 initiated in the last five years and 35 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2023 | 25 |
| 2025 | 6 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code NIE?
NIE is the FDA product code for catheter, hemodialysis, triple lumen, non-implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NIE?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code NIE?
Across 12 cleared submissions the average was 190 days from receipt to decision (median 191).
Which companies have the most NIE clearances?
Medical Components, Inc. (dba MedComp) (3); C.R. Bard, Inc. (3); Medcomp (2); Health Line International Corporation (1); Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (1).
Have NIE devices been recalled?
Yes: 38 product recalls across 8 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NIE
- Run a recall and safety report across every NIE manufacturer
- Watch product code NIE 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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