FDA product code MPB: Catheter, Hemodialysis, Non-Implanted
MPB is the FDA product code for catheter, hemodialysis, 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 38 510(k) submissions under MPB, 1 in the last five years, from 23 different applicants. The average 510(k) review took 225 days (median 200); 145 days on average over the last three years. FDA has posted 24 recalls for MPB devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, 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 MPB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 168 |
| 2020 | 3 | 220 |
| 2025 | 1 | 145 |
Compare with all 510(k) review times · Search every MPB clearance
Top MPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Components, Inc. | 6 | 2025-08-12 |
| C.R. Bard, Inc. | 5 | 2017-04-04 |
| Quinton, Inc. | 5 | 1996-09-13 |
| Arrow Intl., Inc. | 3 | 2000-09-14 |
| Health Line International Corporation | 1 | 2020-12-24 |
18 more applicants have MPB clearances. See the full list in Caduvo.
Most recent MPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250836 | Medical Components, Inc. | 14F Duo-Flow® Side X Side Double Lumen Catheter | 2025-08-12 | 145 |
| K200426 | Health Line International Corporation | Acute Dual Lumen Hemodialysis Catheter | 2020-12-24 | 307 |
| K192807 | Medical Components, Inc. (dba MedComp) | Duo-Flow Side x Side Double Lumen Catheter | 2020-04-23 | 205 |
| K192302 | Covidien, LLC | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter | 2020-01-17 | 147 |
| K163458 | C.R. Bard, Inc. | Zenysis Short-Term Dialysis Catheter | 2017-04-04 | 116 |
Recalls for MPB devices
24 product recalls in 12 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-08-10.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 11 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code MPB?
MPB is the FDA product code for catheter, hemodialysis, 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 MPB?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code MPB?
Across 38 cleared submissions the average was 225 days from receipt to decision (median 200).
Which companies have the most MPB clearances?
Medical Components, Inc. (6); C.R. Bard, Inc. (5); Quinton, Inc. (5); Arrow Intl., Inc. (3); Health Line International Corporation (1).
Have MPB devices been recalled?
Yes: 24 product recalls across 12 recall events; the most recent began 2026-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MPB
- Run a recall and safety report across every MPB manufacturer
- Watch product code MPB 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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